ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER— 510(k) K050874
Substantially EquivalentAstra 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.. Device class: 2.
Clearance details
- Applicant
- Astra Tech, Inc.
- Product code
- Code GBM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Northborough, MA, US
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Adverse events under product code GBM
product code GBM- Injury
- 397
- Malfunction
- 1,404
- Total
- 1,801
Source: openFDA MAUDE database, through . 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.