The following data is part of a premarket notification filed by Cook Vascular, Inc. with the FDA for Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, Steadysheath Evolution Tissue Stabilization Sheath, Steadysheath Evolution Shortie Tissue Stabilization Sheath.
| Device ID | K142301 |
| 510k Number | K142301 |
| Device Name: | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath |
| 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 | 2014-08-18 |
| Decision Date | 2014-11-12 |
| Summary: | summary |