FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XenoSure Biologic Patch
K Number: K190882
·
Decision Feb 13, 2020
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
10
Applicant Total
3
Review Days
315
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Basic Information
- Device Name
- XenoSure Biologic Patch
- K Number
- K190882
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lemaitre Vascular
- Date Received
- April 4, 2019
- Decision Date
- February 13, 2020
- Product Code
- PSQ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- SU
- 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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