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510(k) K191734

MatriStem UBM Pericardial Patch by Acell, Inc. — Product Code PSQ

K191734 is an FDA 510(k) premarket notification submitted by Acell, Inc. for the device "MatriStem UBM Pericardial Patch". The FDA issued a decision of Substantially Equivalent on November 22, 2019. The device falls under product code PSQ (Intracardiac Patch Or Pledget, Biologically Derived), a Class II device regulated under 21 CFR 870.3470. Acell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2019
Date Received
June 28, 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 Acell, Inc.

  • K241724 — Cytal® Wound Matrix; Cytal® Burn Matrix (July 11, 2024)
  • K241706 — MicroMatrix® UBM Particulate (July 11, 2024)
  • K230980 — MicroMatrix® Flex (September 22, 2023)
  • K192725 — Cytal Wound Matrix 3-Layer (October 25, 2019)
  • K182259 — Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal (February 7, 2019)
  • K180776 — Cytal Wound Particulate (May 11, 2018)
  • K172399 — MicroMatrix (October 6, 2017)
  • K170763 — Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend (June 8, 2017)
  • K162554 — Gentrix Surgical Matrix (October 21, 2016)
  • K153754 — MicroMatrix (March 14, 2016)

Other clearances for product code PSQ

  • K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (October 19, 2022)
  • K221032 — Vascu-Guard Vascular Repair Patch (October 19, 2022)
  • K210331 — CardiaMend Pericardial and Epicardial Reconstruction Matrix (December 21, 2021)
  • K200566 — ADAPT Tissue (April 3, 2020)
  • K190882 — XenoSure Biologic Patch (February 13, 2020)
  • 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)

FDA data resources