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 |