ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9— 510(k) K990689

Substantially Equivalent

Zcv ,Inc.

FDA 510(k) clearance K990689 for ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9, Substantially Equivalent on 1999-09-03. Applicant: Zcv ,Inc..

Clearance details

Applicant: Zcv ,Inc.
Product code: Code LJE
Advisory panel: Unknown
Date received: 1999-03-03
Decision date: 1999-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

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Adverse events under product code LJE

product code LJE

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.