VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)— 510(k) K964665
Substantially Equivalent - Subject to Tracking Reg.Carbomedics, Inc.
FDA 510(k) clearance K964665 for VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION), Substantially Equivalent - Subject to Tracking Reg. on 1997-02-19. Applicant: Carbomedics, Inc..
Clearance details
- Applicant
- Carbomedics, Inc.
- Product code
- Code DSY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Austin, TX, US
Adverse events under product code DSY
product code DSY- Death
- 29
- Injury
- 694
- Total
- 723
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.