The following data is part of a premarket notification filed by Vascular Products, Inc. with the FDA for Implantable Pacing Lead, Tined #3262 &.
Device ID | K823447 |
510k Number | K823447 |
Device Name: | IMPLANTABLE PACING LEAD, TINED #3262 & |
Classification | Permanent Pacemaker Electrode |
Applicant | VASCULAR PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DTB |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-16 |
Decision Date | 1982-12-03 |