The following data is part of a premarket notification filed by Cook Vascular, Inc. with the FDA for Evolution Mechanical Dilator Sheath Set Models-lr-evn-7.0, Lr-evn-9.0.
| Device ID | K061000 |
| 510k Number | K061000 |
| Device Name: | EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | COOK VASCULAR, INC. 1186 MONTGOMERY LANE Vandergrift, PA 15690 |
| Contact | Jim Ferguson, Jr |
| Correspondent | Jim Ferguson, Jr COOK VASCULAR, INC. 1186 MONTGOMERY LANE Vandergrift, PA 15690 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-11 |
| Decision Date | 2006-05-10 |
| Summary: | summary |