The following data is part of a premarket notification filed by Biotronik Sales, Inc. with the FDA for Type Yc Endocardial Lead.
Device ID | K810491 |
510k Number | K810491 |
Device Name: | TYPE YC ENDOCARDIAL LEAD |
Classification | Permanent Pacemaker Electrode |
Applicant | BIOTRONIK SALES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTB |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-24 |
Decision Date | 1981-03-20 |