FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PhotoFix Decellularized Bovine Pericardium
K Number: K183635
·
Decision Feb 14, 2019
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
10
Applicant Total
12
Review Days
50
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Basic Information
- Device Name
- PhotoFix Decellularized Bovine Pericardium
- K Number
- K183635
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cryolife, Inc.
- Date Received
- December 26, 2018
- Decision Date
- February 14, 2019
- 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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Other Clearances by Cryolife, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K172085 | PhotoFix Decellularized Bovine Pericardium | Dec 4, 2017 | Substantially Equivalent |
| K162506 | PhotoFix Decellularized Bovine Pericardium | Mar 9, 2017 | Substantially Equivalent |
| K132105 | PERCLOT TOPICAL | Apr 3, 2014 | Substantially Equivalent |
| K110581 | PROPATCH SOFT TISSUE REPAIR MATRIX | Jan 10, 2012 | Substantially Equivalent |
| K101587 | PROPATCH SOFT TISSUE REPAIR MATRIX | Sep 16, 2010 | Substantially Equivalent |
| K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | Jul 23, 2010 | Substantially Equivalent |
| K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) | May 25, 2010 | Substantially Equivalent |
| K091626 | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH | Aug 7, 2009 | Substantially Equivalent |
| K083106 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT | Feb 6, 2009 | Substantially Equivalent |
| K033484 | HUMAN HEART VALVE, CRYOVALVE SG | Feb 7, 2008 | Substantially Equivalent |