FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Columbus Guidewire
K Number: K200374
·
Decision Dec 14, 2020
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
39
Applicant Total
3
Review Days
304
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Basic Information
- Device Name
- Columbus Guidewire
- K Number
- K200374
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rapid-Medical , Ltd.
- Date Received
- February 14, 2020
- Decision Date
- December 14, 2020
- Product Code
- MOF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| MOF | Guide, Wire, Catheter, Neurovasculature | FDA class 2 | Cardiovascular |
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