510(k) K832178 ยท DQY Catheter, Percutaneous
AMPLATZ HEPARIN COATED CATHETER
| Applicant | Cook, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 12, 1983 |
| Received | Jul 6, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832178
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2008 | Cook, Inc. THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm, Cook Incorporated, Bloomington, IN 474 Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.