510(k) K782095 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
STOPCOCKS, MANIFOLDS
| Applicant | Namic, Walker MI, US |
| Decision | Substantially Equivalent, Jan 23, 1979 |
| Received | Dec 18, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K782095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2026 | Medline Industries, LP Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. Open, Classified |
DTL | None listed |
| May 8, 2026 | Medline Industries, LP Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. Open, Classified |
DTL | None listed |
| May 8, 2026 | Medline Industries, LP Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. Open, Classified |
DTL | None listed |
| 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 |
| Nov 9, 2008 | Navilyst Medical NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e. Terminated |
DTZ | None listed |
| Aug 24, 2005 | Boston Scientific Corp ''NAMIC Custom Angiographic Kit'' sold under the following labels:
(1) Medical University of South Carolina. Pouch Catalog # 60131481;
(2) Covenant Medical Center, Pouch Catalog #60131603;
(3) St Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.