The following data is part of a premarket notification filed by Zcv ,inc. with the FDA for Zynergy Featherpace Transvenous Bipolar Catheter, Model 04-x-02-3-10-3.
| Device ID | K002481 |
| 510k Number | K002481 |
| Device Name: | ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-14 |
| Decision Date | 2000-12-07 |