510(k) K031785

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

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)