FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
POWERWIRE RADIOFREQUENCY GUIDEWIRE
K Number: K101615
·
Decision Jul 28, 2010
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
54
Applicant Total
28
Review Days
49
Basic Information
- Device Name
- POWERWIRE RADIOFREQUENCY GUIDEWIRE
- K Number
- K101615
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BAYLIS MEDICAL CO., INC.
- Date Received
- June 9, 2010
- Decision Date
- July 28, 2010
- Product Code
- PDU
- 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 |
|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | FDA class 2 | Cardiovascular |
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