Pharmaseal Div., Baxter Healthcare Corp.
Mchenry, IL, US
Pharmaseal Div., Baxter Healthcare Corp. appears in FDA device records in Mchenry, IL. FDA records list 24 510(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
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Pharmaseal Div., Baxter Healthcare Corp. between 1976 and 1979. The busiest year on record is 1977, with 10. The most recent is 1979, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1977 | 10 |
| 1978 | 3 |
| 1979 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K792369 | HYPERALIMENTATION DRESSING TRAY | FRG | Substantially Equivalent | |
| K792141 | CONTINUOUS FLUSH DEVICE | KRA | Substantially Equivalent | |
| K792019 | PHADECODE XA INHIBITOR ASSAY | JBQ | Substantially Equivalent | |
| K791773 | VENTILATOR TUBE WITH FILTER | CAH | Substantially Equivalent | |
| K791156 | AMIPAQUE MYELOGRAM TRAY | FMI | Substantially Equivalent | |
| K790896 | TWO-WAY ANESTHESIA FILTER | CAH | Substantially Equivalent | |
| K790409 | LOW DEAD SPACE INSULIN SYRINGE | FMF | Substantially Equivalent | |
| K782069 | TRAY, AUXILLARY BLOCK | CAZ | Substantially Equivalent | |
| K781797 | PREP TRAY, PREOPERATIVE SKIN | OJU | Substantially Equivalent | |
| K781680 | MONITORING, PRESSURE KIT | DRS | Substantially Equivalent | |
| K780887 | IMPROVED DISPOSABLE HYPODERMIC NEEDLE | GAA | Substantially Equivalent | |
| K771810 | PRESSURE TUBING | DQO | Substantially Equivalent | |
| K771359 | ALLERGIST PACK SYRINGES | FMF | Substantially Equivalent | |
| K770942 | PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY | JBQ | Substantially Equivalent | |
| K770490 | DRAINAGE BAG, IMPROVED, FLAT | KNX | Substantially Equivalent | |
| K770489 | CATHETER WITH HARD VALVE | KOD | Substantially Equivalent | |
| K770108 | TUBE HOLDING DEVICE | FPK | Substantially Equivalent | |
| K770149 | MAJOR SUTURE REMOVAL TRAY | KDD | Substantially Equivalent | |
| K770256 | CATHETERS, SILICONE COATED | KOD | Substantially Equivalent | |
| K770120 | MOUTH WASH TRAY | FMA | Substantially Equivalent | |
| K761158 | FLUID DISPENSING SYSTEM | FMF | Substantially Equivalent | |
| K761230 | AMMOCENTESIS TRAY (KIT) | HIO | Substantially Equivalent | |
| K761039 | URINARY LEG BAG DRAINAGE TUBE | KNX | Substantially Equivalent | |
| K760069 | BAG, LEG, URINE COLLECTING DEVICE | KNX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CAZAnesthesia Conduction Kit
- JBQAntithrombin Iii Quantitation
- KRACatheter, Continuous Flush
- DQOCatheter, Intravascular, Diagnostic
- KODCatheter, Urological
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- FMADepressor, Tongue, Non-Surgical
- CAHFilter, Bacterial, Breathing-Circuit
- KDDKit, Surgical Instrument, Disposable
- GAANeedle, Aspiration And Injection, Disposable
- FMINeedle, Hypodermic, Single Lumen
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)
- OJUSkin Prep Tray
- FMFSyringe, Piston
- DRSTransducer, Blood-Pressure, Extravascular
- FPKTubing, Fluid Delivery
- FRGWrap, Sterilization
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