REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM— 510(k) K141313
Substantially EquivalentReverse Medical Corporation
FDA 510(k) clearance K141313 for REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM, Substantially Equivalent on 2014-06-18. Applicant: Reverse Medical Corporation.
Clearance details
- Applicant
- Reverse Medical Corporation
- Product code
- Code KRD
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Adverse events under product code KRD
product code KRD- Death
- 119
- Injury
- 1,869
- Malfunction
- 7,015
- Other
- 1
- Total
- 9,004
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.