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FDA 510(k)

CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH

K-Number: K091626 · 2009-08-07

ApplicantCryolife, Inc.
Decision Date2009-08-07
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH is the device name listed in this FDA 510(k) record. The listed applicant is Cryolife, Inc.. It received FDA 510(k) clearance on 2009-08-07 under 510(k) number K091626. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH?

CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH is a medical device that received FDA 510(k) clearance on 2009-08-07. The listed applicant is Cryolife, Inc.. The 510(k) number is K091626.

When did CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH receive FDA 510(k) clearance?

CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH received FDA 510(k) clearance on 2009-08-07, under 510(k) number K091626.

Who is the listed applicant for CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH?

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

What is the FDA product code for CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH?

The FDA product code for CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH is DXZ.

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Other records listing Cryolife, Inc. as applicant

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Related Devices (Code: DXZ)

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.

K240775PeriBeam® Pericardial MembraneTamabioK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.K162579VascuCelAdmedus Regen Pty, Ltd.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.K122306SYNOVIS COLLAGEN MATRIX (TBD)Synovis Surgical Innovations

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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