The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Models 6207/6208/6209/6210/6211/6212/6214 (pli's).
| Device ID | K900515 |
| 510k Number | K900515 |
| Device Name: | MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S) |
| Classification | Introducer, Catheter |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Contact | Lynn M Nordstrom |
| Correspondent | Lynn M Nordstrom MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-02 |
| Decision Date | 1990-08-23 |