CATHETER, TRANSLUMINAL BALLOON
FDA 510(k) clearance K781772 · decided 1979-03-06
Clearance details
- K-number
- K781772
- Device name
- CATHETER, TRANSLUMINAL BALLOON
- Applicant
- Medi-Tech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-10-16
- Decision date
- 1979-03-06
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- GBA
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BYRON WORD BARTHOLIAN GLAND CATHETER (K861877) | Byron Medical | 1986-05-30 |
| BALLOON RETENTION CHEST CATHETER (K802025) | Loseff Medical Designers, Ltd. | 1980-09-26 |
| ELECATH MULTI-PURPOSE ARTERIAL SURGER (K790444) | Electro-Catheter Corp. | 1979-06-11 |
| TUBE, LEATHERMAN/IMBRUCE (K781665) | National Catheter Co. Div. Mallinckrodt | 1978-12-15 |
Recalls involving this device
No recalls on record reference this clearance.