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FDA 510(k)

PhotoFix Decellularized Bovine Pericardium

K-Number: K183635 · 2019-02-14

ApplicantCryolife, Inc.
Decision Date2019-02-14
Product CodePSQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PhotoFix Decellularized Bovine Pericardium is the device name listed in this FDA 510(k) record. The listed applicant is Cryolife, Inc.. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K183635. The device is classified under product code PSQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PhotoFix Decellularized Bovine Pericardium?

PhotoFix Decellularized Bovine Pericardium is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Cryolife, Inc.. The 510(k) number is K183635.

When did PhotoFix Decellularized Bovine Pericardium receive FDA 510(k) clearance?

PhotoFix Decellularized Bovine Pericardium received FDA 510(k) clearance on 2019-02-14, under 510(k) number K183635.

Who is the listed applicant for PhotoFix Decellularized Bovine Pericardium?

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 PhotoFix Decellularized Bovine Pericardium?

The FDA product code for PhotoFix Decellularized Bovine Pericardium is PSQ.

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.

PMA P010003Glue, surgical, arteriesPMA P970029SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATIONK172085PhotoFix Decellularized Bovine PericardiumK162506PhotoFix Decellularized Bovine Pericardium

Related Devices (Code: PSQ)

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.

K221032Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc.K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.K200566ADAPT TissueAdmedus Regen Pty, Ltd.K190882XenoSure Biologic PatchLemaitre VascularK191734MatriStem UBM Pericardial PatchAcell, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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