Panels › General, Plastic Surgery › Product code GBA · Class 1
Catheter, Balloon Type
Regulation 878.4200
0510(k)s in 12 months (5 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in GBA
| Company | 510(k)s | Recalls |
|---|---|---|
| Byron Medical | 1 | 0 |
| Electro-Catheter Corp. | 1 | 0 |
| Karl Storz Endoscopy America Inc | 0 | 1 |
| Loseff Medical Designers, Ltd. | 1 | 0 |
| Medi-Tech, Inc. | 1 | 0 |
| National Catheter Co. Div. Mallinckrodt | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2013 | Karl Storz Endoscopy America Inc 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex.
The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments Terminated |
GBA | None listed |
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