The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Vital-port Vascular Access System Power Injectable Port.
| Device ID | K150733 |
| 510k Number | K150733 |
| Device Name: | Vital-Port Vascular Access System Power Injectable Port |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Steven Lawrie |
| Correspondent | Steven Lawrie COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-20 |
| Decision Date | 2015-05-21 |
| Summary: | summary |