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510(k) K190882

XenoSure Biologic Patch by Lemaitre Vascular — Product Code PSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2020
Date Received
April 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intracardiac Patch Or Pledget, Biologically Derived
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.

Other clearances by Lemaitre Vascular

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  • K182916 — Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid (November 16, 2018)
  • K173323 — AnastoClip GC Closure System (March 8, 2018)
  • K152833 — Pruitt F3-S Polyurethane Carotid Shunt (January 21, 2016)
  • K143454 — Pruitt F3-S Carotid Shunt (August 27, 2015)
  • K142660 — Antegrade LeMills Valvulotome (October 17, 2014)
  • K140042 — 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (April 10, 2014)
  • K133026 — UNBALLOON NON-OCCLUSION MODELING CATHETER (December 31, 2013)

Other clearances for product code PSQ

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  • K210331 — CardiaMend Pericardial and Epicardial Reconstruction Matrix (December 21, 2021)
  • K200566 — ADAPT Tissue (April 3, 2020)
  • K191734 — MatriStem UBM Pericardial Patch (November 22, 2019)
  • K183635 — PhotoFix Decellularized Bovine Pericardium (February 14, 2019)
  • K181038 — CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm (October 10, 2018)
  • K172085 — PhotoFix Decellularized Bovine Pericardium (December 4, 2017)
  • K172660 — Duravess bovine pericardial vascular patch (November 17, 2017)
  • K170951 — CardioCel 3D (April 28, 2017)