510(k) K002603
K002603 is an FDA 510(k) premarket notification submitted by Zcv ,Inc. for the device "ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER". The FDA issued a decision of Substantially Equivalent on January 8, 2001. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Zcv ,Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 2001
- Date Received
- August 22, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Pacemaker, Temporary
- Device Class
- Class II
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type