The following data is part of a premarket notification filed by Cook Vascular, Inc. with the FDA for Cook Vascular Inc. Vital-port Vascular Access System Power Injectable Port.
| Device ID | K081425 |
| 510k Number | K081425 |
| Device Name: | COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | COOK VASCULAR, INC. 1186 MONTGOMERY LANE Vandergrift, PA 15690 |
| Contact | Jim Ferguson |
| Correspondent | Jim Ferguson COOK VASCULAR, INC. 1186 MONTGOMERY LANE Vandergrift, PA 15690 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-21 |
| Decision Date | 2008-09-30 |
| Summary: | summary |