Panels › Gastroenterology, Urology › Product code PID · Class 2
Esophageal Dilator Balloon With Or Without Electrode Sensors
Regulation 876.5980
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PID
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 1 | 0 |
| Covidien, LLC | 0 | 1 |
| Crospon, Ltd. | 1 | 0 |
| Wilson-Cook Medical, Inc. | 1 | 0 |
| 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 | K132337 |
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