Macropore Cardio-Wrap (TS)
FDA 510(k) K031785 · Macropore Biosurgery, Inc.
510(k) numberK031785
Submission
- Device name
- Macropore Cardio-Wrap (TS)
- Applicant
- Macropore Biosurgery, Inc.
San Diego, CA, US - Received
- June 10, 2003
- Decision date
- September 4, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMH – Pericardial Patch To Facilitate Revision Surgeries
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Specialty
- Cardiovascular
- Implant
- Yes
- Life-sustaining
- Yes
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.
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| K012025 | Macropore Surgiwrap (TS)FTL · Traditional | 12/03/2001SE |
| K012769 | Macropore ENT Reconstruction FilmNHB · Traditional | 10/25/2001SE |
| K012413 | Macropore FX, PS, NS, LPJEY · Traditional | 09/18/2001SE |
| K011715 | Macropore Ib Resorbable PlugJDI · Traditional | 08/27/2001SESU |
Questions and answers
When was Macropore Cardio-Wrap (TS) cleared by the FDA?
Macropore Cardio-Wrap (TS) (K031785) received a 510(k) decision of Substantially Equivalent on September 4, 2003, 86 days after the submission was received.
What is the product code of K031785?
The FDA product code is OMH – Pericardial Patch To Facilitate Revision Surgeries, a Class II (moderate risk) device regulated under 21 CFR 870.3470.