ULTRA LOW POROSITY DACRON WOVEN PATCH— 510(k) K921659
UnknownIntervascular, Inc.
FDA 510(k) clearance K921659 for ULTRA LOW POROSITY DACRON WOVEN PATCH, Unknown on 1992-11-25. Applicant: Intervascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Intervascular, Inc.
- Product code
- Code DXZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.3470
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Clearwater, FL, US
Recent devices under product code DXZ
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- K983819 — INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
- K970843 — INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
- K964625 — HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
Adverse events under product code DXZ
product code DXZ- Death
- 19
- Injury
- 265
- Total
- 284
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.