FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XableCath Crossing Catheter
K Number: K183357
·
Decision Jan 21, 2019
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
56
Applicant Total
3
Review Days
48
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Basic Information
- Device Name
- XableCath Crossing Catheter
- K Number
- K183357
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xablecath, Inc.
- Date Received
- December 4, 2018
- Decision Date
- January 21, 2019
- 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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