GBA — Catheter, Balloon Type Class I
FDA product code GBA covers "Catheter, Balloon Type", a Class I medical device regulated under 21 CFR 878.4200. Submissions are reviewed by the General, Plastic Surgery panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GBA
- Device Class
- Class I
- Regulation Number
- 878.4200
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K861877 | byron medical | BYRON WORD BARTHOLIAN GLAND CATHETER | May 30, 1986 |
| K802025 | loseff medical designers | BALLOON RETENTION CHEST CATHETER | September 26, 1980 |
| K790444 | electro-catheter | ELECATH MULTI-PURPOSE ARTERIAL SURGER | June 11, 1979 |
| K781772 | medi-tech | CATHETER, TRANSLUMINAL BALLOON | March 6, 1979 |
| K781665 | national catheter co. div. mallinckrodt | TUBE, LEATHERMAN/IMBRUCE | December 15, 1978 |