510(k) K842829 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS
| Applicant | North American Instrument Corp., Hudson Falls NY, US |
| Decision | Substantially Equivalent, Oct 18, 1984 |
| Received | Jul 20, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842829
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2021 | Medline Industries Inc NAMIC Manifolds.
(1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile;
(2) NAMIC Angiographic MAN Terminated |
DTL | None listed |
| Aug 6, 2021 | Medline Industries Inc NAMIC Stopcocks:
(1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile;
(2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, Terminated |
DTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.