The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Balloon Temp. Pacing Catheter.
| Device ID | K822003 |
| 510k Number | K822003 |
| Device Name: | BALLOON TEMP. PACING CATHETER |
| 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 |