HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES— 510(k) K964625
Substantially Equivalent - Subject to Tracking Reg.Intervascular, Inc.
FDA 510(k) clearance K964625 for HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES, Substantially Equivalent - Subject to Tracking Reg. on 1997-05-05. Applicant: Intervascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Intervascular, Inc.
- Product code
- Code DSY
- Device class
- Class 2
- Regulation
- 21 CFR 870.3450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Clearwater, FL, US
Recent devices under product code DSY
view allMore clearances from Intervascular, Inc.
view all- K990800 — INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS
- K984294 — MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
- K983819 — INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
- K970843 — INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
- K921659 — ULTRA LOW POROSITY DACRON WOVEN PATCH
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.