FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Comet Pressure Guidewire
K Number: K151610
·
Decision Oct 6, 2015
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
63
Applicant Total
231
Review Days
113
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Basic Information
- Device Name
- Comet Pressure Guidewire
- K Number
- K151610
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2870
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- June 15, 2015
- Decision Date
- October 6, 2015
- Product Code
- DXO
- 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 |
|---|---|---|---|
| DXO | Transducer, Pressure, Catheter Tip | FDA class 2 | Cardiovascular |
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