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510(k) K031785

MACROPORE CARDIO-WRAP (TS) by Macropore Biosurgery, Inc. — Product Code OMH

K031785 is an FDA 510(k) premarket notification submitted by Macropore Biosurgery, Inc. for the device "MACROPORE CARDIO-WRAP (TS)". The FDA issued a decision of Substantially Equivalent on September 4, 2003. The device falls under product code OMH (Pericardial Patch To Facilitate Revision Surgeries), a Class II device regulated under 21 CFR 870.3470. Macropore Biosurgery, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2003
Date Received
June 10, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pericardial Patch To Facilitate Revision Surgeries
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

Pericardial patch or pledget with the secondary function of facilitating revision surgeries by providing a plane of dissection. Does not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of cardiac surgery.

Other clearances by Macropore Biosurgery, Inc.

  • K042261 — MACROPORE PURICEL LIPOPLASTY SYSTEM (September 20, 2004)
  • K041105 — MACROPORE HYDROSORB SPINE SYSTEM (July 28, 2004)
  • K031955 — MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET (September 22, 2003)
  • K024169 — MACROPORE OS RECONSTRUCTION (July 1, 2003)
  • K023643 — MACROPORE SURGICAL BARRIER FILM (February 21, 2003)
  • K021164 — MACROPORE OS TRAUMA (July 1, 2002)
  • K012025 — MACROPORE SURGIWRAP (TS) (December 3, 2001)
  • K012769 — MACROPORE ENT RECONSTRUCTION FILM (October 25, 2001)
  • K012413 — MACROPORE FX, PS, NS, LP (September 18, 2001)
  • K011715 — MACROPORE IB RESORBABLE PLUG (August 27, 2001)

FDA data resources