The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Vital-port(r) Ct Vascular Access System.
| Device ID | K140169 |
| 510k Number | K140169 |
| Device Name: | VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Thomas J Kardos |
| Correspondent | Thomas J Kardos COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-23 |
| Decision Date | 2014-05-21 |
| Summary: | summary |