510(k) K931009 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
TYSHAK PERIPHERAL BALLOON DILATION CATHETER
| Applicant | NuMED, Inc., Hopkinton NY, US |
| Decision | Substantially Equivalent, Dec 21, 1993 |
| Received | Feb 19, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931009
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2009 | Numed Inc IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only
--- Common/Usual Name: PTA and Esophageal Catheter
--- Manufactured for: B. Braun Interv Terminated |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.