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FDA 510(k)

VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)

K-Number: K964665 · 1997-02-19

ApplicantCarbomedics, Inc.
Decision Date1997-02-19
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1997-02-19 under 510(k) number K964665. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)?

VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) is a medical device that received FDA 510(k) clearance on 1997-02-19. The listed applicant is Carbomedics, Inc.. The 510(k) number is K964665.

When did VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) receive FDA 510(k) clearance?

VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) received FDA 510(k) clearance on 1997-02-19, under 510(k) number K964665.

Who is the listed applicant for VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)?

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

What is the FDA product code for VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)?

The FDA product code for VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) is DSY.

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Other records listing Carbomedics, Inc. as applicant

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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

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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