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FDA 510(k)

PROPATCH SOFT TISSUE REPAIR MATRIX

K-Number: K061892 · 2006-11-22

ApplicantCryolife, Inc.
Decision Date2006-11-22
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 2006-11-22 under 510(k) number K061892. 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 2006-11-22. The listed applicant is Cryolife, Inc.. The 510(k) number is K061892.

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

PROPATCH SOFT TISSUE REPAIR MATRIX received FDA 510(k) clearance on 2006-11-22, under 510(k) number K061892.

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

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.

K183635PhotoFix Decellularized Bovine PericardiumK172085PhotoFix Decellularized Bovine PericardiumK162506PhotoFix Decellularized Bovine PericardiumK110581PROPATCH SOFT TISSUE REPAIR MATRIXK101587PROPATCH SOFT TISSUE REPAIR MATRIXK101866CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH

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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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