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FDA 510(k)

SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS

K-Number: K013022 · 2002-06-13

ApplicantSulzer Carbomedics, Inc.
Decision Date2002-06-13
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Carbomedics, Inc.. It received FDA 510(k) clearance on 2002-06-13 under 510(k) number K013022. 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 SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS?

SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS is a medical device that received FDA 510(k) clearance on 2002-06-13. The listed applicant is Sulzer Carbomedics, Inc.. The 510(k) number is K013022.

When did SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS receive FDA 510(k) clearance?

SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS received FDA 510(k) clearance on 2002-06-13, under 510(k) number K013022.

Who is the listed applicant for SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS?

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

What is the FDA product code for SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS?

The FDA product code for SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS is DSY.

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Other records listing Sulzer 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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