FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ER-REBOA PLUS Catheter
K Number: K193440
·
Decision Jan 9, 2020
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
89
Applicant Total
5
Review Days
29
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Basic Information
- Device Name
- ER-REBOA PLUS Catheter
- K Number
- K193440
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Prytime Medical Devices, Inc.
- Date Received
- December 11, 2019
- Decision Date
- January 9, 2020
- 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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