Cardio-Wrap

FDA 510(k) K090637 · Mast Biosurgery USA, Inc.

Unknown

510(k) numberK090637

Submission

Device name
Cardio-Wrap
Applicant
Mast Biosurgery USA, Inc.
San Diego, CA, US
Received
March 10, 2009
Decision date
January 7, 2010
Decision
Unknown (SESU)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3470
Specialty
Cardiovascular
Implant
Yes

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K142461VASCU-GUARD Peripheral Vascular PatchDXZ · Traditional Synovis Life Technologies, Inc.11/25/2014SE
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K130872CardiocelDXZ · Traditional Celxcel Pty, Ltd.01/30/2014SE

More from Celxcel Pty, Ltd.

510(k)DeviceDecision
K063648Surgi-Wrap Mast Tendon SheetFTL · Traditional 03/07/2007SE
K061473Surgi-Wrap Mast Bioresorbable SheetFTL · Traditional 09/21/2006SE
K050332Surgi-Wrap Mast Bioresorbable SheetFTL · Traditional 05/27/2005SE

Questions and answers

When was Cardio-Wrap cleared by the FDA?

Cardio-Wrap (K090637) received a 510(k) decision of Unknown on January 7, 2010, 303 days after the submission was received.

What is the product code of K090637?

The FDA product code is DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 870.3470.