Company ยท US
American Pharmaseal Div. Ahsc
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1987. Name variants (Inc, Corp, punctuation) are merged.
64510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KOD | Catheter, Urological | 6 |
| DQY | Catheter, Percutaneous | 5 |
| BSY | Catheters, Suction, Tracheobronchial | 4 |
| DRS | Transducer, Blood-Pressure, Extravascular | 3 |
| FSH | Tray, Surgical, Needle | 3 |
| FSM | Tray, Surgical, Instrument | 3 |
| BYY | Tube, Aspirating, Flexible, Connecting | 2 |
| FLL | Continuous Measurement Thermometer | 2 |
| FMG | Stopcock, I.V. Set | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 |
| FRO | Dressing, Wound, Drug | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 |
| BZB | Catheter, Nasal, Oxygen | 1 |
| CAC | Apparatus, Autotransfusion | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 30, 1987 | K874022 | PHARMASEAL WOUND IRRIGATION DEVICE American Pharmaseal Div. Ahsc | FQH |
| Dec 3, 1987 | K874517 | PHARMASEAL RUBBER URETHRAL CATHETER American Pharmaseal Div. Ahsc | KOD |
| Dec 3, 1987 | K874045 | PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER American Pharmaseal Div. Ahsc | NWU |
| Nov 6, 1987 | K873359 | AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE American Pharmaseal Div. Ahsc | CAI |
| Sep 4, 1987 | K872228 | PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM American Pharmaseal Div. Ahsc | FNM |
| Aug 11, 1987 | K872917 | JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER American Pharmaseal Div. Ahsc | BSY |
| Aug 10, 1987 | K871429 | ANTIMICROBIAL FOLEY CATHETER American Pharmaseal Div. Ahsc | KOD |
| Jun 26, 1987 | K871770 | AMERICAN PHARMASEAL WOUND DRESSING American Pharmaseal Div. Ahsc | FRO |
| May 8, 1987 | K870387 | EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE American Pharmaseal Div. Ahsc | BTR |
| Apr 1, 1987 | K870977 | PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE American Pharmaseal Div. Ahsc | KOD |
| Mar 27, 1987 | K870941 | PHARMASEAL WOUND CARE DRESSING PAD American Pharmaseal Div. Ahsc | KOZ |
| Mar 27, 1987 | K870704 | CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET American Pharmaseal Div. Ahsc | GBX |
| Mar 17, 1987 | K870720 | AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE American Pharmaseal Div. Ahsc | CBT |
| Dec 1, 1986 | K864397 | DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBE American Pharmaseal Div. Ahsc | FLL |
| Jun 16, 1986 | K861677 | PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT American Pharmaseal Div. Ahsc | CAC |
| May 5, 1986 | K861165 | PHARMASEAL DUAL LUMEN CATHETER American Pharmaseal Div. Ahsc | DQY |
| Jan 13, 1986 | K853714 | PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA American Pharmaseal Div. Ahsc | DQY |
| Dec 10, 1985 | K854232 | PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES American Pharmaseal Div. Ahsc | GEC |
| Dec 3, 1985 | K854012 | AMERICAN PHARMASEAL HUMIDAIR CONDENSER American Pharmaseal Div. Ahsc | BYD |
| Sep 25, 1985 | K852491 | AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER American Pharmaseal Div. Ahsc | DQY |
| Sep 12, 1985 | K853207 | PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE American Pharmaseal Div. Ahsc | KOD |
| Aug 6, 1985 | K851334 | AIRLIFE ELECTRONIC INCENTIVE SPIROMETER American Pharmaseal Div. Ahsc | BWF |
| May 9, 1985 | K850119 | PHARMASEAL EYE PREP TRAY American Pharmaseal Div. Ahsc | HNR |
| Apr 5, 1985 | K850265 | AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE American Pharmaseal Div. Ahsc | CAH |
| Mar 22, 1985 | K850266 | AMERICAN PHARMASEAL STERILE I.V. START KIT American Pharmaseal Div. Ahsc | |
| Aug 30, 1984 | K842860 | AMERICAN PHARMASEAL I.V. START KIT American Pharmaseal Div. Ahsc | |
| Aug 20, 1984 | K842542 | AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY American Pharmaseal Div. Ahsc | FMI |
| Jul 9, 1984 | K841544 | AMER. PHARMASEAL SILICONIZED LATEX American Pharmaseal Div. Ahsc | KOD |
| Jun 28, 1984 | K842380 | PRESSURE RELIEF SEAT CUSHION American Pharmaseal Div. Ahsc | KIC |
| Jun 25, 1984 | K842198 | AMER. PHARMASEAL NO TOUCH SATIN CATHET American Pharmaseal Div. Ahsc | BSY |
| Apr 24, 1984 | K840797 | MALE-MALE LUER LOCK CONNECTOR W/ROTA American Pharmaseal Div. Ahsc | DTL |
| Mar 19, 1984 | K840394 | STOPCOCKS & EXTENSION TUBES American Pharmaseal Div. Ahsc | FMG |
| Mar 12, 1984 | K840664 | TRACHEOSTOMY CLEANING TRAY American Pharmaseal Div. Ahsc | BSY |
| Jan 19, 1984 | K832407 | DECUBITUS CARE ABSORBENT DRESSING American Pharmaseal Div. Ahsc | FRO |
| Jan 10, 1984 | K832907 | INVASIVE MONITORING KITS American Pharmaseal Div. Ahsc | DRS |
| Sep 12, 1983 | K832556 | NEONATAL LUMBAR PUNCTURE TRAY American Pharmaseal Div. Ahsc | FMI |
| Jul 18, 1983 | K831807 | CATHETER INSERTION TRAYS, VARIOUS #'S American Pharmaseal Div. Ahsc | DQY |
| Jul 18, 1983 | K831730 | CONTINUOUS FLUSH DEVICE American Pharmaseal Div. Ahsc | KRA |
| Jul 18, 1983 | K831729 | PERCUTANEOUS CATHETER INSERTION TRAY American Pharmaseal Div. Ahsc | DQY |
| Apr 18, 1983 | K830210 | DISPOSABLE PRESSURE TRANSDUCER American Pharmaseal Div. Ahsc | DRS |
| Apr 6, 1983 | K830839 | AMER. 400 SERIES TEMP. PROBES-RECTALL American Pharmaseal Div. Ahsc | FLL |
| Oct 27, 1982 | K822811 | CONTAINERS OF STERILE WATER OS SALINE American Pharmaseal Div. Ahsc | BTO |
| Sep 2, 1982 | K822443 | NASO-GARD NASOGASTRIC TUBE HOLDER American Pharmaseal Div. Ahsc | KNT |
| Jul 20, 1982 | K821894 | DISPOSABLE TRANSDUCER DOMES & KITS American Pharmaseal Div. Ahsc | DRS |
| Apr 16, 1982 | K820370 | NASAL OXYGEN CATHETER American Pharmaseal Div. Ahsc | BZB |
| Apr 16, 1982 | K820369 | SUCTION CATHETERS & KITS American Pharmaseal Div. Ahsc | BSY |
| Apr 1, 1982 | K820371 | PLASTIC CONNECTORS American Pharmaseal Div. Ahsc | BYY |
| Mar 31, 1982 | K820412 | AM. PH. STERILE PLASTIC CONNECTING TUBES American Pharmaseal Div. Ahsc | BYY |
| Mar 23, 1982 | K820420 | AM. PH. STERILE FEEDING TUBE American Pharmaseal Div. Ahsc | KNT |
| Mar 23, 1982 | K820419 | AM. PH. STERILE SINGLE-USE URETHRAL CATH American Pharmaseal Div. Ahsc | KOD |
Newest 50 of 64.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||