The following data is part of a premarket notification filed by Cook Vascular, Inc. with the FDA for Evolution Rl Controlled-rotation Dilator Sheath Set, Evolution Shortie Rl Controlled-rotation Dilator Sheath Set.
| Device ID | K141148 |
| 510k Number | K141148 |
| Device Name: | EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | COOK VASCULAR, INC. 1186 MONTGOMERY LANE Vandergrift, PA 15690 |
| Contact | Thomas J Kardos |
| Correspondent | Thomas J Kardos COOK VASCULAR, INC. 1186 MONTGOMERY LANE Vandergrift, PA 15690 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-05 |
| Decision Date | 2014-07-01 |
| Summary: | summary |