The following data is part of a premarket notification filed by Cook Vascular, Inc. with the FDA for Cook Vascular Electrosurgical Dissection Sheath.
| Device ID | K010055 |
| 510k Number | K010055 |
| Device Name: | COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | COOK VASCULAR, INC. RT. 66, RIVER RD. P.O. BOX 529 Leechburg, PA 15656 -0529 |
| Contact | Thomas J Kardos |
| Correspondent | Thomas J Kardos COOK VASCULAR, INC. RT. 66, RIVER RD. P.O. BOX 529 Leechburg, PA 15656 -0529 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-08 |
| Decision Date | 2001-06-14 |