FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERFADEX SOLUTION FOR LUNG PRESERVATION
K Number: K022730
·
Decision Oct 27, 2003
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
12
Applicant Total
3
Review Days
437
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Basic Information
- Device Name
- PERFADEX SOLUTION FOR LUNG PRESERVATION
- K Number
- K022730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vitrolife AB
- Date Received
- August 16, 2002
- Decision Date
- October 27, 2003
- Product Code
- MSB
- 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 |
|---|---|---|---|
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | FDA class 2 | Gastroenterology, Urology |
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