The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Permanent Lead Introducer.
| Device ID | K854559 |
| 510k Number | K854559 |
| Device Name: | MEDTRONIC PERMANENT LEAD INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
| Contact | Alan Marquardt |
| Correspondent | Alan Marquardt MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-14 |
| Decision Date | 1985-12-24 |