Company ยท US
Pharmaseal Div., Baxter Healthcare Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1979. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FMF | Syringe, Piston | 3 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 3 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 |
| JBQ | Antithrombin Iii Quantitation | 2 |
| KOD | Catheter, Urological | 2 |
| CAZ | Anesthesia Conduction Kit | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| FMA | Depressor, Tongue, Non-Surgical | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| FPK | Tubing, Fluid Delivery | 1 |
| FRG | Wrap, Sterilization | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 |
| KRA | Catheter, Continuous Flush | 1 |
| OJU | Skin Prep Tray | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 10, 1979 | K792369 | HYPERALIMENTATION DRESSING TRAY Pharmaseal Div., Baxter Healthcare Corp. | FRG |
| Dec 5, 1979 | K792141 | CONTINUOUS FLUSH DEVICE Pharmaseal Div., Baxter Healthcare Corp. | KRA |
| Nov 5, 1979 | K792019 | PHADECODE XA INHIBITOR ASSAY Pharmaseal Div., Baxter Healthcare Corp. | JBQ |
| Oct 22, 1979 | K791773 | VENTILATOR TUBE WITH FILTER Pharmaseal Div., Baxter Healthcare Corp. | CAH |
| Jul 30, 1979 | K791156 | AMIPAQUE MYELOGRAM TRAY Pharmaseal Div., Baxter Healthcare Corp. | FMI |
| Jun 5, 1979 | K790896 | TWO-WAY ANESTHESIA FILTER Pharmaseal Div., Baxter Healthcare Corp. | CAH |
| Apr 24, 1979 | K790409 | LOW DEAD SPACE INSULIN SYRINGE Pharmaseal Div., Baxter Healthcare Corp. | FMF |
| Jan 4, 1979 | K782069 | TRAY, AUXILLARY BLOCK Pharmaseal Div., Baxter Healthcare Corp. | CAZ |
| Nov 8, 1978 | K781797 | PREP TRAY, PREOPERATIVE SKIN Pharmaseal Div., Baxter Healthcare Corp. | OJU |
| Oct 6, 1978 | K781680 | MONITORING, PRESSURE KIT Pharmaseal Div., Baxter Healthcare Corp. | DRS |
| Jun 22, 1978 | K780887 | IMPROVED DISPOSABLE HYPODERMIC NEEDLE Pharmaseal Div., Baxter Healthcare Corp. | GAA |
| Nov 17, 1977 | K771810 | PRESSURE TUBING Pharmaseal Div., Baxter Healthcare Corp. | DQO |
| Aug 22, 1977 | K771359 | ALLERGIST PACK SYRINGES Pharmaseal Div., Baxter Healthcare Corp. | FMF |
| Jul 21, 1977 | K770942 | PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY Pharmaseal Div., Baxter Healthcare Corp. | JBQ |
| Mar 21, 1977 | K770490 | DRAINAGE BAG, IMPROVED, FLAT Pharmaseal Div., Baxter Healthcare Corp. | KNX |
| Mar 21, 1977 | K770489 | CATHETER WITH HARD VALVE Pharmaseal Div., Baxter Healthcare Corp. | KOD |
| Mar 10, 1977 | K770108 | TUBE HOLDING DEVICE Pharmaseal Div., Baxter Healthcare Corp. | FPK |
| Feb 25, 1977 | K770149 | MAJOR SUTURE REMOVAL TRAY Pharmaseal Div., Baxter Healthcare Corp. | KDD |
| Feb 17, 1977 | K770256 | CATHETERS, SILICONE COATED Pharmaseal Div., Baxter Healthcare Corp. | KOD |
| Jan 28, 1977 | K770120 | MOUTH WASH TRAY Pharmaseal Div., Baxter Healthcare Corp. | FMA |
| Jan 26, 1977 | K761158 | FLUID DISPENSING SYSTEM Pharmaseal Div., Baxter Healthcare Corp. | FMF |
| Dec 17, 1976 | K761230 | AMMOCENTESIS TRAY (KIT) Pharmaseal Div., Baxter Healthcare Corp. | HIO |
| Dec 2, 1976 | K761039 | URINARY LEG BAG DRAINAGE TUBE Pharmaseal Div., Baxter Healthcare Corp. | KNX |
| Oct 20, 1976 | K760069 | BAG, LEG, URINE COLLECTING DEVICE Pharmaseal Div., Baxter Healthcare Corp. | KNX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||