H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007— 510(k) K020951

Substantially Equivalent

Ackrad Laboratories

FDA 510(k) clearance K020951 for H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007, Substantially Equivalent on 2002-04-16. Applicant: Ackrad Laboratories.

Clearance details

Applicant: Ackrad Laboratories
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2002-03-25
Decision date: 2002-04-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Cranford, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

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.