Travenol Laboratories, S.A.
Mchenry, IL, US
Travenol Laboratories, S.A. appears in FDA device records in Mchenry, IL. FDA records list 206 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 206
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 206FDA records hold 206 510(k) clearances for Travenol Laboratories, S.A. between 1976 and 1988. The busiest year on record is 1983, with 24. The most recent is 1988, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 14 |
| 1977 | 20 |
| 1978 | 20 |
| 1979 | 13 |
| 1980 | 19 |
| 1981 | 9 |
| 1982 | 16 |
| 1983 | 24 |
| 1984 | 17 |
| 1985 | 20 |
| 1986 | 20 |
| 1987 | 13 |
| 1988 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K874181 | BAXTER BEDSIDE SYSTEM | FRN | Substantially Equivalent | |
| K873894 | CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE | FPA | Substantially Equivalent | |
| K873873 | RESUBMITTED MICRON TRANSFUSION FILTER | CAK | Substantially Equivalent | |
| K873984 | AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) | KDJ | Substantially Equivalent | |
| K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | FII | Substantially Equivalent | |
| K872652 | UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM | FKX | Substantially Equivalent | |
| K870801 | FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD | FRN | Substantially Equivalent | |
| K871908 | IV ADMINISTRATION SET | BRZ | Substantially Equivalent | |
| K871471 | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 | FJI | Substantially Equivalent | |
| K865029 | CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER | FPB | Substantially Equivalent | |
| K870169 | CAPILLARY FLOW DIALYZERS | FJI | Substantially Equivalent | |
| K870940 | SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC. | FPA | Substantially Equivalent | |
| K870145 | EXTERNAL Y VALVE 5C4198 | KDJ | Substantially Equivalent | |
| K863864 | AMBULATORY INFUSION PUMP, MODEL AS30C | FRN | Substantially Equivalent | |
| K863468 | EXACTECH(TM) | CGA | Substantially Equivalent | |
| K864338 | SECONDARY SET LOCK | FPA | Substantially Equivalent | |
| K860353 | SYRINGE INFUSION PUMP | FRN | Substantially Equivalent | |
| K861761 | ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE | LPZ | Substantially Equivalent | |
| K861618 | TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024) | KNT | Substantially Equivalent | |
| K861776 | HIGH EFFICIENCY HEMODIALYSIS SYSTEM | KDI | Substantially Equivalent | |
| K862152 | TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD | KJA | Substantially Equivalent | |
| K860362 | SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER | KNX | Substantially Equivalent | |
| K860162 | FLO-GARD 6200 VOLUMETRIC INFUSION PUMP | FRN | Substantially Equivalent | |
| K860833 | EPIDURAL ANESTHESIA TRAY | CAZ | Substantially Equivalent | |
| K861253 | TISSUE CULTURE FLASK PL 732 PLASTIC | KJA | Substantially Equivalent | |
| K853663 | ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR | LPZ | Substantially Equivalent | |
| K860746 | AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER | FPB | Substantially Equivalent | |
| K860700 | CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186 | KDJ | Substantially Equivalent | |
| K860541 | SOLUTION ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K860272 | SOLUTION ADMINISTRATION SETS | FPA | Substantially Equivalent | |
| K854168 | TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES | ELA | Substantially Equivalent | |
| K854863 | FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER | LDR | Substantially Equivalent | |
| K855003 | BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732 | KNW | Substantially Equivalent | |
| K860230 | CAPD TRANSFER SET SPIKE 5C4363 | KDJ | Substantially Equivalent | |
| K854586 | HOLLOW FIBER DIALYZER | KDI | Substantially Equivalent | |
| K854517 | NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET | FKK | Substantially Equivalent | |
| K853881 | THE TRAVENOL 5 ML/HR INFUSOR | FRN | Substantially Equivalent | |
| K853830 | SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST | LHI | Substantially Equivalent | |
| K842905 | TRAVENOL MULTIDAY INFUSOR 2C1080 | FRN | Substantially Equivalent | |
| K853550 | TRAVENOL CAPD Y SET 5C4354 | KDJ | Substantially Equivalent | |
| K853208 | 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY | CHP | Substantially Equivalent | |
| K852678 | CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353 | KDJ | Substantially Equivalent | |
| K851940 | STERILE WATER FOR INHALATION USP 2D0799 | BTT | Substantially Equivalent | |
| K851074 | VARIABLE NEBULIZER HEATER | CAF | Substantially Equivalent | |
| K850637 | EXOTHERMIC HEATING PAD | IMD | Substantially Equivalent | |
| K851208 | COMPACT EXCHANGE DEVICE 5C4197 | KDJ | Substantially Equivalent | |
| K851207 | EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 | KDJ | Substantially Equivalent | |
| K850710 | TRAVENOL FLO-GARD 500 IV MONITOR | FLN | Substantially Equivalent | |
| K850061 | MICRO VOLUME DOUBLE LINE EXTENSION SET | FPA | Substantially Equivalent | |
| K850756 | AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS | FKR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CAZAnesthesia Conduction Kit
- BYOBottle, Blow
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- JCYCatheter, Infusion
- GBXCatheter, Irrigation
- FKOCatheter, Peritoneal Dialysis, Single Use
- FOSCatheter, Umbilical Artery
- BSYCatheters, Suction, Tracheobronchial
- FKKClamp, Line
- DTPDefoamer, Cardiopulmonary Bypass
- FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable
- FJIDialyzer, Capillary, Hollow Fiber
- FJHDialyzer, Disposable
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- FJGDialyzer, Parallel Flow
- FHSDialyzer, Single Coil
- DIFDrug Mixture Control Materials
- FPBFilter, Infusion Line
- KJAFlask, Tissue Culture
- CGAGlucose Oxidase, Glucose
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- FRCIndicator, Biological Sterilization Process
- ELAInstrument, Hand, Calculus Removal
- FHXJelly, Lubricating, For Transurethral Surgical Instrument
- CAKMicrofilter, Blood Transfusion
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- FLNMonitor, Electric For Gravity Flow Infusion Systems
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CAFNebulizer (Direct Patient Interface)
- GAANeedle, Aspiration And Injection, Disposable
- FIENeedle, Fistula
- FMINeedle, Hypodermic, Single Lumen
- JZWNephelometer
- DTZOxygenator, Cardiopulmonary Bypass
- IMDPack, Hot Or Cold, Disposable
- FRNPump, Infusion
- DPORadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
- CHPRadioimmunoassay, Estradiol
- CEWRadioimmunoassay, Parathyroid Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- DTNReservoir, Blood, Cardiopulmonary Bypass
- GKTSeparator, Automated, Blood Cell, Diagnostic
- KDJSet, Administration, For Peritoneal Dialysis, Disposable
- FPASet, Administration, Intravascular
- BRZSet, Blood Transfusion
- BZOSet, Tubing And Support, Ventilator (W Harness)
- FMGStopcock, I.V. Set
- FKRSubsystem, Proportioning
- KGOSurgeon'S Gloves
- FMFSyringe, Piston
- FKQSystem, Dialysate Delivery, Central Multiple Patient
- FIISystem, Dialysate Delivery, Sealed
- FILSystem, Dialysate Delivery, Single Pass
- FKPSystem, Dialysate Delivery, Single Patient
- FKXSystem, Peritoneal, Automatic Delivery
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- KNTTubes, Gastrointestinal (And Accessories)
- JHIVisual, Pregnancy Hcg, Prescription Use
- BSBWarmer, Blood, Non-Electromagnetic Radiation
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain