FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCS Lung Solution
K Number: K211314
·
Decision Jul 29, 2021
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
12
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- OCS Lung Solution
- K Number
- K211314
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TransMedics, Inc.
- Date Received
- April 30, 2021
- Decision Date
- July 29, 2021
- 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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