VAS-CATH DUALATOR(TM) VESSEL DILATOR
FDA 510(k) clearance K914210 · decided 1993-07-01
Clearance details
- K-number
- K914210
- Device name
- VAS-CATH DUALATOR(TM) VESSEL DILATOR
- Applicant
- Vas-Cath, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-09-19
- Decision date
- 1993-07-01
- Days to decision
- 651 days
- Clearance type
- Traditional
- Product code
- FKA
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mississauga, Ontario, CA
- 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 |
|---|---|---|
| SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT (K022620) | Spire Biomedical, Inc. | 2002-10-11 |
| VESSEL DILATORS (K910502) | Akcess Medical Products, Inc. | 1991-04-29 |
Recalls involving this device
No recalls on record reference this clearance.