ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000— 510(k) K991060
Substantially EquivalentZcv ,Inc.
FDA 510(k) clearance K991060 for ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000, Substantially Equivalent on 2000-04-06. Applicant: Zcv ,Inc.. Device class: 2.
Clearance details
- Applicant
- Zcv ,Inc.
- Product code
- Code DRF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edison, NJ, US
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- K002481 — ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
- K990689 — ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
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.