SF SH CATHETER, MODEL R65-945— 510(k) K013437

Substantially Equivalent

A & A Medical, Inc.

FDA 510(k) clearance K013437 for SF SH CATHETER, MODEL R65-945, Substantially Equivalent on 2001-11-19. Applicant: A & A Medical, Inc..

Clearance details

Applicant: A & A Medical, Inc.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2001-10-17
Decision date: 2001-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, 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.