510(k) K981035 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES
| Applicant | Sims Portex, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Apr 21, 1998 |
| Received | Mar 19, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981035
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2018 | Smiths Medical ASD Inc. Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH. Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.