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FDA 510(k)

VASCUTEK CANNULA GRAFT, MODEL CGS2008S

K-Number: K081560 · 2009-02-10

ApplicantVascutek, Ltd.
Decision Date2009-02-10
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCUTEK CANNULA GRAFT, MODEL CGS2008S is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 2009-02-10 under 510(k) number K081560. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCUTEK CANNULA GRAFT, MODEL CGS2008S?

VASCUTEK CANNULA GRAFT, MODEL CGS2008S is a medical device that received FDA 510(k) clearance on 2009-02-10. The listed applicant is Vascutek, Ltd.. The 510(k) number is K081560.

When did VASCUTEK CANNULA GRAFT, MODEL CGS2008S receive FDA 510(k) clearance?

VASCUTEK CANNULA GRAFT, MODEL CGS2008S received FDA 510(k) clearance on 2009-02-10, under 510(k) number K081560.

Who is the listed applicant for VASCUTEK CANNULA GRAFT, MODEL CGS2008S?

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

What is the FDA product code for VASCUTEK CANNULA GRAFT, MODEL CGS2008S?

The FDA product code for VASCUTEK CANNULA GRAFT, MODEL CGS2008S is DWF.

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Other records listing Vascutek, Ltd. as applicant

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Related Devices (Code: DWF)

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

View on FDA Database →

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

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