INTRAVASCULAR RETRIEVAL DEVICE
FDA 510(k) clearance K981061 · decided 1998-05-26
Clearance details
- K-number
- K981061
- Device name
- INTRAVASCULAR RETRIEVAL DEVICE
- Applicant
- Med Institute, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-23
- Decision date
- 1998-05-26
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- GCC
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- West Lafayette, IN, 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 |
|---|---|---|
| BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET (K922354) | Med Institute, Inc. | 1992-07-30 |
| BYRD STAINLESS STEEL DILATOR (K902502) | Medical Engineering and Development Institute | 1990-08-07 |
| BYRD EXTRACTOR SET (K893480) | Medical Engineering and Development Institute | 1989-06-23 |
| VAN-TEC FASCIAL DILATOR (K820865) | Van-Tec, Inc. | 1982-05-05 |
Recalls involving this device
No recalls on record reference this clearance.