ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE— 510(k) K011847
Substantially EquivalentZynergy Cardio Vasular (Zcv), Inc.
FDA 510(k) clearance K011847 for ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE, Substantially Equivalent on 2001-07-13. Applicant: Zynergy Cardio Vasular (Zcv), Inc..
Clearance details
- Applicant
- Zynergy Cardio Vasular (Zcv), Inc.
- Product code
- Code DRF
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Edison, NJ, US
Adverse events under product code DRF
product code DRF- Death
- 127
- Injury
- 1,676
- Malfunction
- 2,003
- Other
- 1
- Total
- 3,807
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.