DEUTSCH ANTI-BLOCKAGE WOUND DRAIN— 510(k) K052286
Substantially EquivalentThe Catheter Exchange, Inc.
FDA 510(k) clearance K052286 for DEUTSCH ANTI-BLOCKAGE WOUND DRAIN, Substantially Equivalent on 2005-10-21. Applicant: The Catheter Exchange, Inc..
Clearance details
- Applicant
- The Catheter Exchange, Inc.
- Product code
- Code GBX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Encino, CA, US
Adverse events under product code GBX
product code GBX- Death
- 16
- Injury
- 583
- Malfunction
- 3,578
- Other
- 1
- Total
- 4,178
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.