American Pharmaseal Div. Ahsc
Mchenry, IL, US
American Pharmaseal Div. Ahsc appears in FDA device records in Mchenry, IL. FDA records list 64 510(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
- 64
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 64FDA records hold 64 510(k) clearances for American Pharmaseal Div. Ahsc between 1980 and 1987. The busiest year on record is 1987, with 13. The most recent is 1987, with 13.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 5 |
| 1981 | 6 |
| 1982 | 12 |
| 1983 | 6 |
| 1984 | 10 |
| 1985 | 8 |
| 1986 | 4 |
| 1987 | 13 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K874022 | PHARMASEAL WOUND IRRIGATION DEVICE | FQH | Substantially Equivalent | |
| K874517 | PHARMASEAL RUBBER URETHRAL CATHETER | KOD | Substantially Equivalent | |
| K874045 | PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER | NWU | Substantially Equivalent | |
| K873359 | AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE | CAI | Substantially Equivalent | |
| K872228 | PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM | FNM | Substantially Equivalent | |
| K872917 | JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER | BSY | Substantially Equivalent | |
| K871429 | ANTIMICROBIAL FOLEY CATHETER | KOD | Substantially Equivalent | |
| K871770 | AMERICAN PHARMASEAL WOUND DRESSING | FRO | Substantially Equivalent for Some Indications | |
| K870387 | EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | |
| K870977 | PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE | KOD | Substantially Equivalent | |
| K870941 | PHARMASEAL WOUND CARE DRESSING PAD | KOZ | Substantially Equivalent | |
| K870704 | CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET | GBX | Unknown | |
| K870720 | AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE | CBT | Substantially Equivalent | |
| K864397 | DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBE | FLL | Substantially Equivalent | |
| K861677 | PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT | CAC | Substantially Equivalent | |
| K861165 | PHARMASEAL DUAL LUMEN CATHETER | DQY | Substantially Equivalent | |
| K853714 | PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA | DQY | Substantially Equivalent | |
| K854232 | PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES | GEC | Substantially Equivalent for Some Indications | |
| K854012 | AMERICAN PHARMASEAL HUMIDAIR CONDENSER | BYD | Substantially Equivalent | |
| K852491 | AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER | DQY | Substantially Equivalent | |
| K853207 | PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE | KOD | Substantially Equivalent | |
| K851334 | AIRLIFE ELECTRONIC INCENTIVE SPIROMETER | BWF | Substantially Equivalent | |
| K850119 | PHARMASEAL EYE PREP TRAY | HNR | Substantially Equivalent | |
| K850265 | AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE | CAH | Substantially Equivalent | |
| K850266 | AMERICAN PHARMASEAL STERILE I.V. START KIT | Substantially Equivalent | ||
| K842860 | AMERICAN PHARMASEAL I.V. START KIT | Substantially Equivalent | ||
| K842542 | AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY | FMI | Substantially Equivalent | |
| K841544 | AMER. PHARMASEAL SILICONIZED LATEX | KOD | Substantially Equivalent | |
| K842380 | PRESSURE RELIEF SEAT CUSHION | KIC | Substantially Equivalent | |
| K842198 | AMER. PHARMASEAL NO TOUCH SATIN CATHET | BSY | Substantially Equivalent | |
| K840797 | MALE-MALE LUER LOCK CONNECTOR W/ROTA | DTL | Substantially Equivalent | |
| K840394 | STOPCOCKS & EXTENSION TUBES | FMG | Substantially Equivalent | |
| K840664 | TRACHEOSTOMY CLEANING TRAY | BSY | Substantially Equivalent | |
| K832407 | DECUBITUS CARE ABSORBENT DRESSING | FRO | Substantially Equivalent | |
| K832907 | INVASIVE MONITORING KITS | DRS | Substantially Equivalent | |
| K832556 | NEONATAL LUMBAR PUNCTURE TRAY | FMI | Substantially Equivalent | |
| K831807 | CATHETER INSERTION TRAYS, VARIOUS #'S | DQY | Substantially Equivalent | |
| K831730 | CONTINUOUS FLUSH DEVICE | KRA | Substantially Equivalent | |
| K831729 | PERCUTANEOUS CATHETER INSERTION TRAY | DQY | Substantially Equivalent | |
| K830210 | DISPOSABLE PRESSURE TRANSDUCER | DRS | Substantially Equivalent | |
| K830839 | AMER. 400 SERIES TEMP. PROBES-RECTALL | FLL | Substantially Equivalent | |
| K822811 | CONTAINERS OF STERILE WATER OS SALINE | BTO | Substantially Equivalent | |
| K822443 | NASO-GARD NASOGASTRIC TUBE HOLDER | KNT | Substantially Equivalent | |
| K821894 | DISPOSABLE TRANSDUCER DOMES & KITS | DRS | Substantially Equivalent | |
| K820370 | NASAL OXYGEN CATHETER | BZB | Substantially Equivalent | |
| K820369 | SUCTION CATHETERS & KITS | BSY | Substantially Equivalent | |
| K820371 | PLASTIC CONNECTORS | BYY | Substantially Equivalent | |
| K820412 | AM. PH. STERILE PLASTIC CONNECTING TUBES | BYY | Substantially Equivalent | |
| K820420 | AM. PH. STERILE FEEDING TUBE | KNT | Substantially Equivalent | |
| K820419 | AM. PH. STERILE SINGLE-USE URETHRAL CATH | KOD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- CACApparatus, Autotransfusion
- KXFApplicator, Absorbent Tipped, Non-Sterile
- CBTArterial Blood Sampling Kit
- KOZBeads, Hydrophilic, For Wound Exudate Absorption
- GECBrush, Scrub, Operating-Room
- KRACatheter, Continuous Flush
- GBXCatheter, Irrigation
- BZBCatheter, Nasal, Oxygen
- DQYCatheter, Percutaneous
- FKOCatheter, Peritoneal Dialysis, Single Use
- KODCatheter, Urological
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BYDCondenser, Heat And Moisture (Artificial Nose)
- FMHContainer, Specimen, Sterile
- FLLContinuous Measurement Thermometer
- KICCushion, Flotation
- FRODressing, Wound, Drug
- NWUEndoscope Introducer Kit
- CAHFilter, Bacterial, Breathing-Circuit
- HNRForceps, Ophthalmic
- FQHLavage, Jet
- FNMMattress, Air Flotation, Alternating Pressure
- FMINeedle, Hypodermic, Single Lumen
- DTZOxygenator, Cardiopulmonary Bypass
- KRBProbe, Thermodilution
- LHISet, I.V. Fluid Transfer
- BWFSpirometer, Therapeutic (Incentive)
- FMGStopcock, I.V. Set
- DRSTransducer, Blood-Pressure, Extravascular
- FSMTray, Surgical, Instrument
- FSHTray, Surgical, Needle
- BYYTube, Aspirating, Flexible, Connecting
- BTRTube, Tracheal (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- KNTTubes, Gastrointestinal (And Accessories)
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