FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CARDIO-WRAP
K Number: K090637
·
Decision Jan 7, 2010
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
89
Applicant Total
4
Review Days
303
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
- CARDIO-WRAP
- K Number
- K090637
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Mast Biosurgery USA, Inc.
- Date Received
- March 10, 2009
- Decision Date
- January 7, 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