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FDA 510(k)

PROPATCH SOFT TISSUE REPAIR MATRIX

K-Number: K101587 · 2010-09-16

ApplicantCryolife, Inc.
Decision Date2010-09-16
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROPATCH SOFT TISSUE REPAIR MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Cryolife, Inc.. It received FDA 510(k) clearance on 2010-09-16 under 510(k) number K101587. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPATCH SOFT TISSUE REPAIR MATRIX?

PROPATCH SOFT TISSUE REPAIR MATRIX is a medical device that received FDA 510(k) clearance on 2010-09-16. The listed applicant is Cryolife, Inc.. The 510(k) number is K101587.

When did PROPATCH SOFT TISSUE REPAIR MATRIX receive FDA 510(k) clearance?

PROPATCH SOFT TISSUE REPAIR MATRIX received FDA 510(k) clearance on 2010-09-16, under 510(k) number K101587.

Who is the listed applicant for PROPATCH SOFT TISSUE REPAIR MATRIX?

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 PROPATCH SOFT TISSUE REPAIR MATRIX?

The FDA product code for PROPATCH SOFT TISSUE REPAIR MATRIX is FTM.

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Other records listing Cryolife, Inc. as applicant

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K183635PhotoFix Decellularized Bovine PericardiumK172085PhotoFix Decellularized Bovine PericardiumK162506PhotoFix Decellularized Bovine PericardiumK110581PROPATCH SOFT TISSUE REPAIR MATRIXK101866CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCHK092021CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)

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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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