STATLOCK IV CONNECTOR AND ANCHOR SET— 510(k) K902109

Substantially Equivalent

Venetec, Inc.

FDA 510(k) clearance K902109 for STATLOCK IV CONNECTOR AND ANCHOR SET, Substantially Equivalent on 1990-10-19. Applicant: Venetec, Inc..

Clearance details

Applicant: Venetec, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1990-05-09
Decision date: 1990-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.