INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN— 510(k) K983819
Substantially EquivalentIntervascular, Inc.
FDA 510(k) clearance K983819 for INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN, Substantially Equivalent on 1998-11-24. 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
- Clearance type
- Special
- 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
- K970843 — INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
- K964625 — HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS 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.