FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Advance 14LP Low Profile PTA Balloon Dilatation Catheter
K Number: K170193
·
Decision Feb 13, 2017
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
175
Review Days
21
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Basic Information
- Device Name
- Advance 14LP Low Profile PTA Balloon Dilatation Catheter
- K Number
- K170193
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- January 23, 2017
- Decision Date
- February 13, 2017
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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