Dilator, Vessel
FDA product code FKA · Class II (moderate risk) · 21 CFR 876.5540 · Gastroenterology, Urology
3510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022620 | Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and XrikrtFKA · Traditional | Spire Biomedical, Inc. | 10/11/2002SE |
| K914210 | Vas-Cath Dualator(Tm) Vessel DilatorFKA · Traditional | Vas-Cath, Inc. | 07/01/1993SE |
| K910502 | Vessel DilatorsFKA · Traditional | Akcess Medical Products, Inc. | 04/29/1991SE |