The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Balloon Pacing Catheter.
Device ID | K851246 |
510k Number | K851246 |
Device Name: | NUMED BALLOON PACING CATHETER |
Classification | Electrode, Pacemaker, Temporary |
Applicant | NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
Contact | Allen J Tower |
Correspondent | Allen J Tower NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
Product Code | LDF |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-25 |
Decision Date | 1985-04-19 |