FDA 510(k)

INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS

K-Number: K990800 · 2001-01-08

Decision Date2001-01-08

Product CodeDSY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Intervascular, Inc.. It received FDA 510(k) clearance on 2001-01-08 under 510(k) number K990800. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS?

INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS is a medical device that received FDA 510(k) clearance on 2001-01-08. The listed applicant is Intervascular, Inc.. The 510(k) number is K990800.

When did INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS receive FDA 510(k) clearance?

INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS received FDA 510(k) clearance on 2001-01-08, under 510(k) number K990800.

Who is the listed applicant for INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS?

The FDA 510(k) record lists Intervascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS?

The FDA product code for INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS is DSY.

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Other records listing Intervascular, Inc. as applicant

K984294MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES K983819INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN K970843INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES K964625HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES K921659ULTRA LOW POROSITY DACRON WOVEN PATCH K913143OCHSNER ULP BIFURCATION VASCULAR PROTHESIS

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.