510(k) K132337 ยท PID Esophageal Dilator Balloon With Or Without Electrode Sensors
ESOFLIP BALLOON DILATION CATHETER
| Applicant | Crospon, Ltd., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Oct 7, 2013 |
| Received | Jul 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132337
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2024 | Covidien, LLC EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only Open, Classified |
PID | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.