FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DuraGraft
K Number: DEN230002
·
Decision Oct 4, 2023
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
1
Review Days
274
Basic Information
- Device Name
- DuraGraft
- K Number
- DEN230002
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.4100
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Marizyme, Inc.
- Date Received
- January 3, 2023
- Decision Date
- October 4, 2023
- Product Code
- QEJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| QEJ | Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries | FDA class 2 | Gastroenterology, Urology |
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