FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH
K Number: K091626
·
Decision Aug 7, 2009
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
89
Applicant Total
12
Review Days
65
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Basic Information
- Device Name
- CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH
- K Number
- K091626
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cryolife, Inc.
- Date Received
- June 3, 2009
- Decision Date
- August 7, 2009
- 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 |
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| K083106 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT | Feb 6, 2009 | Substantially Equivalent |
| K033484 | HUMAN HEART VALVE, CRYOVALVE SG | Feb 7, 2008 | Substantially Equivalent |