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510(k) K821532

PERIGUARD PERICARDIAL PATCH by Genetic Laboratories, Inc. — Product Code DXZ

K821532 is an FDA 510(k) premarket notification submitted by Genetic Laboratories, Inc. for the device "PERIGUARD PERICARDIAL PATCH". The FDA issued a decision of Substantially Equivalent on August 19, 1982. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Genetic Laboratories, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1982
Date Received
May 24, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

Other clearances by Genetic Laboratories, Inc.

  • K842066 — PERI-GUARD PERICARDIAL PATCH (December 30, 1985)
  • K842621 — SUTURE STRIP (October 25, 1984)

Other clearances for product code DXZ

  • K240775 — PeriBeam® Pericardial Membrane (April 18, 2025)
  • K200955 — Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (July 8, 2020)
  • K162506 — PhotoFix Decellularized Bovine Pericardium (March 9, 2017)
  • K162579 — VascuCel (October 14, 2016)
  • K152127 — CorMatrix Tyke (February 4, 2016)
  • K151865 — PremiPatch PTFE Pledget (October 27, 2015)
  • K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (January 7, 2015)
  • K142461 — VASCU-GUARD Peripheral Vascular Patch (November 25, 2014)
  • K140789 — CORMATRIX ECM FOR VASCULAR REPAIR (July 15, 2014)
  • K130872 — CARDIOCEL (January 30, 2014)

FDA data resources