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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 30, 1986 | K861877 | BYRON WORD BARTHOLIAN GLAND CATHETER Byron Medical | GBA |
| Sep 26, 1980 | K802025 | BALLOON RETENTION CHEST CATHETER Loseff Medical Designers, Ltd. | GBA |
| Jun 11, 1979 | K790444 | ELECATH MULTI-PURPOSE ARTERIAL SURGER Electro-Catheter Corp. | GBA |
| Mar 6, 1979 | K781772 | CATHETER, TRANSLUMINAL BALLOON Medi-Tech, Inc. | GBA |
| Dec 15, 1978 | K781665 | TUBE, LEATHERMAN/IMBRUCE National Catheter Co. Div. Mallinckrodt | GBA |
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