Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Duravess bovine pericardial vascular patch

K-Number: K172660 · 2017-11-17

ApplicantEdwards Lifesciences, LLC
Decision Date2017-11-17
Product CodePSQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Duravess bovine pericardial vascular patch is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K172660. 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 Duravess bovine pericardial vascular patch?

Duravess bovine pericardial vascular patch is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K172660.

When did Duravess bovine pericardial vascular patch receive FDA 510(k) clearance?

Duravess bovine pericardial vascular patch received FDA 510(k) clearance on 2017-11-17, under 510(k) number K172660.

Who is the listed applicant for Duravess bovine pericardial vascular patch?

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

What is the FDA product code for Duravess bovine pericardial vascular patch?

The FDA product code for Duravess bovine pericardial vascular patch is PSQ.

Related Clinical Trials

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.

NCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITINGNCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITINGNCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITINGNCT03745313Edwards CLASP TR EFSCOMPLETEDNCT04097145Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialRECRUITINGNCT04375332Beating Heart Mitral Valve Repair With the HARPOON™ SystemACTIVE_NOT_RECRUITING

Other records listing Edwards Lifesciences, LLC 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 P230013Percutaneously Delivered Prostheses and Tricuspid ValvesPMA P860057replacement Heart-valvePMA P250019Prosthesis, mitral valve, percutaneously deliveredPMA P220003Mitral valve repair devicesPMA P200015Pulmonary valve prosthesis percutaneously deliveredPMA P150048heart-valve, non-allograft tissue

View all 81 devices →

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

View on FDA Database →

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

↑