The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Bipolar Temp. Pacing Catheter W/styletet.
Device ID | K822002 |
510k Number | K822002 |
Device Name: | BIPOLAR TEMP. PACING CATHETER W/STYLETET |
Classification | Electrode, Pacemaker, Temporary |
Applicant | ZIEHM INTERNATIONAL, INC. 906-A COMMERCE RD. Annapolis, MD 21401 |
Product Code | LDF |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-08 |
Decision Date | 1982-10-15 |