H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)— 510(k) K953034

Substantially Equivalent

Ackrad Laboratories

FDA 510(k) clearance K953034 for H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607), Substantially Equivalent on 1995-08-29. Applicant: Ackrad Laboratories.

Clearance details

Applicant: Ackrad Laboratories
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 1995-06-19
Decision date: 1995-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranford, NJ, US

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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.