FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CardiaMend Pericardial and Epicardial Reconstruction Matrix
K Number: K210331
·
Decision Dec 21, 2021
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
10
Applicant Total
1
Review Days
319
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Basic Information
- Device Name
- CardiaMend Pericardial and Epicardial Reconstruction Matrix
- K Number
- K210331
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Helios Cardio, Inc.
- Date Received
- February 5, 2021
- Decision Date
- December 21, 2021
- Product Code
- PSQ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | FDA class 2 | Cardiovascular |
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