CardioCel 3D
FDA 510(k) K170951 · Admedus Regen Pty, Ltd.
510(k) numberK170951
Submission
- Device name
- CardioCel 3D
- Applicant
- Admedus Regen Pty, Ltd.
Malaga, AU - Received
- March 31, 2017
- Decision date
- April 28, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PSQ – Intracardiac Patch Or Pledget, Biologically Derived
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Specialty
- Cardiovascular
- Implant
- Yes
To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
Other 510(k)s with product code PSQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221032 | Vascu-Guard Vascular Repair PatchPSQ · Traditional | Synovis Life Technologies, Inc. | 10/19/2022SE |
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchPSQ · Traditional | Synovis Life Technologies, Inc. | 10/19/2022SE |
| K210331 | CardiaMend Pericardial and Epicardial Reconstruction MatrixPSQ · Traditional | Helios Cardio, Inc. | 12/21/2021SE |
| K200566 | ADAPT TissuePSQ · Special | Admedus Regen Pty, Ltd. | 04/03/2020SE |
| K190882 | XenoSure Biologic PatchPSQ · Traditional | Lemaitre Vascular | 02/13/2020SE |
| K191734 | MatriStem UBM Pericardial PatchPSQ · Traditional | Acell, Inc. | 11/22/2019SE |
| K183635 | PhotoFix Decellularized Bovine PericardiumPSQ · Special | Cryolife, Inc. | 02/14/2019SE |
| K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…PSQ · Traditional | Cormatrix Cardiovascular, Inc. | 10/10/2018SE |
| K172085 | PhotoFix Decellularized Bovine PericardiumPSQ · Traditional | Cryolife, Inc. | 12/04/2017SE |
| K172660 | Duravess bovine pericardial vascular patchPSQ · Traditional | Edwards Lifesciences, LLC | 11/17/2017SE |
More from Edwards Lifesciences, LLC
Questions and answers
When was CardioCel 3D cleared by the FDA?
CardioCel 3D (K170951) received a 510(k) decision of Substantially Equivalent on April 28, 2017, 28 days after the submission was received.
What is the product code of K170951?
The FDA product code is PSQ – Intracardiac Patch Or Pledget, Biologically Derived, a Class II (moderate risk) device regulated under 21 CFR 870.3470.