The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for Pro-vent, Pulsator Arterial Blood Sampling Syringes.
| Device ID | K981035 |
| 510k Number | K981035 |
| Device Name: | PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-19 |
| Decision Date | 1998-04-21 |
| Summary: | summary |