MEADOX EXXCEL EPTFE VASCULAR GRAFT— 510(k) K962433
Substantially Equivalent - Subject to Tracking Reg.Meadox Medicals, Div. Boston Scientific Corp.
FDA 510(k) clearance K962433 for MEADOX EXXCEL EPTFE VASCULAR GRAFT, Substantially Equivalent - Subject to Tracking Reg. on 1997-03-17. Applicant: Meadox Medicals, Div. Boston Scientific Corp..
Clearance details
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
- Product code
- Code DSY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Oakland, NJ, 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.