FDA Product Code
FDA Product Code FKA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5540
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K022620 | SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT | Spire Biomedical, Inc. | 2002-10-11 | Traditional | PDF ↗ |
| K914210 | VAS-CATH DUALATOR(TM) VESSEL DILATOR | Vas-Cath, Inc. | 1993-07-01 | Traditional | PDF ↗ |
| K910502 | VESSEL DILATORS | Akcess Medical Products, Inc. | 1991-04-29 | Traditional | PDF ↗ |
Product code FKA · Class II · Gastroenterology, Urology. Data: openFDA.