FDA Product Code
FDA Product Code GBA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4200
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K861877 | BYRON WORD BARTHOLIAN GLAND CATHETER | Byron Medical | 1986-05-30 | Traditional | PDF ↗ |
| K802025 | BALLOON RETENTION CHEST CATHETER | Loseff Medical Designers, Ltd. | 1980-09-26 | Traditional | PDF ↗ |
| K790444 | ELECATH MULTI-PURPOSE ARTERIAL SURGER | Electro-Catheter Corp. | 1979-06-11 | Traditional | PDF ↗ |
| K781772 | CATHETER, TRANSLUMINAL BALLOON | Medi-Tech, Inc. | 1979-03-06 | Traditional | PDF ↗ |
| K781665 | TUBE, LEATHERMAN/IMBRUCE | National Catheter Co. Div. Mallinckrodt | 1978-12-15 | Traditional | PDF ↗ |
Product code GBA · Class I · General, Plastic Surgery. Data: openFDA.