FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
exGraft, exGraft Carbon
K Number: K183613
·
Decision Apr 22, 2019
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
187
Applicant Total
4
Review Days
117
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Basic Information
- Device Name
- exGraft, exGraft Carbon
- K Number
- K183613
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Peca Labs
- Date Received
- December 26, 2018
- Decision Date
- April 22, 2019
- Product Code
- DSY
- 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 |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | FDA class 2 | Cardiovascular |
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