VICKERS MEDICAL MODEL 112 TREONIC DC2
FDA 510(k) clearance K791645 · decided 1979-10-02
Clearance details
- K-number
- K791645
- Device name
- VICKERS MEDICAL MODEL 112 TREONIC DC2
- Applicant
- Vickers America Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-08-23
- Decision date
- 1979-10-02
- Days to decision
- 40 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 |
| VESSEL TIPS, SIZES 13-18 (K810257) | Quinton, Inc. | 1981-03-13 |
Recalls involving this device
No recalls on record reference this clearance.