MatriStem UBM Pericardial Patch— 510(k) K191734

Substantially Equivalent

Acell, Inc.

FDA 510(k) clearance K191734 for MatriStem UBM Pericardial Patch, Substantially Equivalent on 2019-11-22. Applicant: Acell, Inc.. Device class: 2.

Clearance details

Applicant: Acell, Inc.
Product code: Code PSQ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2019-06-28
Decision date: 2019-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PSQ

K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch2022-10-19
K221032 — Vascu-Guard Vascular Repair Patch2022-10-19
K210331 — CardiaMend Pericardial and Epicardial Reconstruction Matrix2021-12-21
K200566 — ADAPT Tissue2020-04-03
K190882 — XenoSure Biologic Patch2020-02-13

More clearances from Acell, Inc.

K241706 — MicroMatrix® UBM Particulate2024-07-11
K241724 — Cytal® Wound Matrix; Cytal® Burn Matrix2024-07-11
K230980 — MicroMatrix® Flex2023-09-22
K192725 — Cytal Wound Matrix 3-Layer2019-10-25
K182259 — Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal2019-02-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.