FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
K Number: K101866
·
Decision Jul 23, 2010
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
89
Applicant Total
12
Review Days
21
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
- K Number
- K101866
- 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
- July 2, 2010
- Decision Date
- July 23, 2010
- Product Code
- DXZ
- 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 |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXZ), ordered by most recent decision date.
PeriBeam® Pericardial Membrane
FDA 510(k)
FDA Class 2
·Cardiovascular
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
FDA 510(k)
FDA Class 2
·Cardiovascular
PhotoFix Decellularized Bovine Pericardium
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuCel
FDA 510(k)
FDA Class 2
·Cardiovascular
CorMatrix Tyke
FDA 510(k)
FDA Class 2
·Cardiovascular
PremiPatch PTFE Pledget
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Cryolife, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K183635 | PhotoFix Decellularized Bovine Pericardium | Feb 14, 2019 | Substantially Equivalent |
| 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 |
| 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 |