ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER— 510(k) K050874

Substantially Equivalent

Astra Tech, Inc.

FDA 510(k) clearance K050874 for ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER, Substantially Equivalent on 2005-05-05. Applicant: Astra Tech, Inc..

Clearance details

Applicant: Astra Tech, Inc.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 2005-04-06
Decision date: 2005-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Northborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GBM

product code GBM

Injury: 397
Malfunction: 1,404
Total: 1,801

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.