FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AortaSTAT Occlusion Device
K Number: K210602
·
Decision Jul 9, 2021
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
88
Applicant Total
1
Review Days
130
Basic Information
- Device Name
- AortaSTAT Occlusion Device
- K Number
- K210602
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RenalPro Medical, Inc.
- Date Received
- March 1, 2021
- Decision Date
- July 9, 2021
- Product Code
- MJN
- 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 |
|---|---|---|---|
| MJN | Catheter, Intravascular Occluding, Temporary | FDA class 2 | Cardiovascular |
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