ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
FDA 510(k) clearance K002603 · decided 2001-01-08
Clearance details
- K-number
- K002603
- Device name
- ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
- Applicant
- Zcv ,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-22
- Decision date
- 2001-01-08
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.