The following data is part of a premarket notification filed by Medical Engineering And Development Institute with the FDA for Life-line(tm) Vascular Access System.
| Device ID | K895030 |
| 510k Number | K895030 |
| Device Name: | LIFE-LINE(TM) VASCULAR ACCESS SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Fearnot, Phd |
| Correspondent | Fearnot, Phd MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE P.O. BOX 2402 West Lafayette, IN 47906 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-08 |
| Decision Date | 1990-04-17 |