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FDA 510(k)

CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES

K-Number: K103347 · 2011-02-02

ApplicantIntervascular Sas
Decision Date2011-02-02
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES is the device name listed in this FDA 510(k) record. The listed applicant is Intervascular Sas. It received FDA 510(k) clearance on 2011-02-02 under 510(k) number K103347. 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 CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES?

CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES is a medical device that received FDA 510(k) clearance on 2011-02-02. The listed applicant is Intervascular Sas. The 510(k) number is K103347.

When did CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES receive FDA 510(k) clearance?

CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES received FDA 510(k) clearance on 2011-02-02, under 510(k) number K103347.

Who is the listed applicant for CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES?

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

What is the FDA product code for CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES?

The FDA product code for CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES is DSY.

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Related Devices (Code: DSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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