VESSEL TIPS, SIZES 13-18
FDA 510(k) clearance K810257 · decided 1981-03-13
Clearance details
- K-number
- K810257
- Device name
- VESSEL TIPS, SIZES 13-18
- Applicant
- Quinton, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-01-30
- Decision date
- 1981-03-13
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- FKW
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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 |
|---|---|---|
| T SERIES VESSEL TIPS (K893438) | Akcess Medical Products, Inc. | 1989-06-08 |
| VICKERS MEDICAL MODEL 112 TREONIC DC2 (K791645) | Vickers America Medical Corp. | 1979-10-02 |
Recalls involving this device
No recalls on record reference this clearance.