FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pure Flow External Counter-Pulsation Device
K Number: K173483
·
Decision May 30, 2018
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
33
Applicant Total
4
Review Days
198
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Basic Information
- Device Name
- Pure Flow External Counter-Pulsation Device
- K Number
- K173483
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5225
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xtreem Pulse, LLC
- Date Received
- November 13, 2017
- Decision Date
- May 30, 2018
- Product Code
- DRN
- 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 |
|---|---|---|---|
| DRN | Device, Counter-Pulsating, External | FDA class 2 | Cardiovascular |
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