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510(k) K021129

CHARE CARIOVASCULAR PATCH by Chase Medical, Inc. — Product Code DXZ

K021129 is an FDA 510(k) premarket notification submitted by Chase Medical, Inc. for the device "CHARE CARIOVASCULAR PATCH". The FDA issued a decision of Substantially Equivalent on June 3, 2002. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Chase Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2002
Date Received
April 8, 2002
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 Chase Medical, Inc.

  • K072473 — CHASE MR SYSTEM (December 10, 2007)
  • K062031 — CHASE CARDIAC ANALYSIS SYSTEM (September 27, 2006)
  • K032531 — CHASE CARDIAC ANALYSIS SYSTEM (February 2, 2004)
  • K022093 — CHASE CARDIOVASCULAR PATCH KIT (September 20, 2002)
  • K020233 — CHASE CARDIOVASCULAR PATCH KIT (March 14, 2002)
  • K020132 — CHASE CARDIOVASCULAR PATCH KIT (February 26, 2002)
  • K012248 — CHASE CARDIOVASCULAR PATCH (August 10, 2001)
  • K003467 — CHASE CARDIOVASCULAR PATCH (January 29, 2001)
  • K001662 — CHASE CARDIOVASCULAR PATCH (August 2, 2000)
  • K972993 — CHASE FEMORAL ACCESS CANNULATION SET (March 31, 1998)

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