The following data is part of a premarket notification filed by Zcv ,inc. with the FDA for Z2 Balloon Guided Pacing & Pressure Monitoring Catheter, Model Z2-7-02-1-10-0.
| Device ID | K003118 |
| 510k Number | K003118 |
| Device Name: | Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 |
| Classification | Catheter, Flow Directed |
| 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 | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-05 |
| Decision Date | 2000-12-20 |