510(k) K023504 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Nov 13, 2002 |
| Received | Oct 18, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023504
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.