FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
K Number: K233783
·
Decision Jan 17, 2024
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
187
Applicant Total
1
Review Days
51
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Basic Information
- Device Name
- exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
- K Number
- K233783
- 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, Inc.
- Date Received
- November 27, 2023
- Decision Date
- January 17, 2024
- 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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