T SERIES VESSEL TIPS
FDA 510(k) clearance K893438 · decided 1989-06-08
Clearance details
- K-number
- K893438
- Device name
- T SERIES VESSEL TIPS
- Applicant
- Akcess Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-03
- Decision date
- 1989-06-08
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- FKW
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- New Brunswick, NJ, 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 |
|---|---|---|
| VESSEL TIPS, SIZES 13-18 (K810257) | Quinton, Inc. | 1981-03-13 |
| 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.