FKA — Dilator, Vessel Class II
FDA product code FKA covers "Dilator, Vessel", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FKA
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K022620 | spire biomedical | SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIK | October 11, 2002 |
| K914210 | vas-cath | VAS-CATH DUALATOR(TM) VESSEL DILATOR | July 1, 1993 |
| K910502 | akcess medical products | VESSEL DILATORS | April 29, 1991 |