FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Straub Endovascular System
K Number: K172315
·
Decision Apr 12, 2018
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
1
Review Days
254
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Basic Information
- Device Name
- Straub Endovascular System
- K Number
- K172315
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Straub Medical AG
- Date Received
- August 1, 2017
- Decision Date
- April 12, 2018
- Product Code
- MCW
- 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 |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | FDA class 2 | Cardiovascular |
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