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510(k) K130872

CARDIOCEL by Celxcel Pty, Ltd. — Product Code DXZ

K130872 is an FDA 510(k) premarket notification submitted by Celxcel Pty, Ltd. for the device "CARDIOCEL". The FDA issued a decision of Substantially Equivalent on January 30, 2014. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2014
Date Received
March 29, 2013
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

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  • 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)
  • K122306 — SYNOVIS COLLAGEN MATRIX (TBD) (March 8, 2013)

FDA data resources