GUARDIANCATHETER-URINARY DRAINAGE CATHETER— 510(k) K063795
Substantially EquivalentMarian Medical, Inc.
FDA 510(k) clearance K063795 for GUARDIANCATHETER-URINARY DRAINAGE CATHETER, Substantially Equivalent on 2007-03-05. Applicant: Marian Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Marian Medical, 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
- Traditional
- Location
- Louisville, KY, US
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More clearances from Marian Medical, Inc.
view allAdverse 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.