510(k) K983373 ยท KNQ Dilator, Esophageal
IMPACT BALLOON DILATION CATHETER
| Applicant | B. Braun/Mcgaw, Bethlehem PA, US |
| Decision | Substantially Equivalent, Jun 22, 1999 |
| Received | Sep 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983373
| 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.