FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROSCOUT STEERABLE GUIDEWIRE
K Number: K100351
·
Decision Mar 16, 2010
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
152
Review Days
32
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Basic Information
- Device Name
- NEUROSCOUT STEERABLE GUIDEWIRE
- K Number
- K100351
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- February 12, 2010
- Decision Date
- March 16, 2010
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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FDA 510(k)
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