The following data is part of a premarket notification filed by Zcv ,inc. with the FDA for Zynergy Z3k Balloon Guided Pacing And Monitoring Catheter.
| Device ID | K010099 |
| 510k Number | K010099 |
| Device Name: | ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | ZCV ,INC. 298 FERNWOOD AVE. Edison, NJ 08837 |
| Contact | Jing Zhang |
| Correspondent | Jing Zhang ZCV ,INC. 298 FERNWOOD AVE. Edison, NJ 08837 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-11 |
| Decision Date | 2001-02-01 |