FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tunnel Crossing Catheter
K Number: K221163
·
Decision Jan 19, 2023
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
56
Applicant Total
3
Review Days
272
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Tunnel Crossing Catheter
- K Number
- K221163
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tractus Vascular, LLC
- Date Received
- April 22, 2022
- Decision Date
- January 19, 2023
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PDU), ordered by most recent decision date.
Santreva-ATK Endovascular Revasculariztion Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
PowerWire® 14 Radiofrequency Guidewire Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
LimFlow ARC
FDA 510(k)
FDA Class 2
·Cardiovascular
PowerWire Radiofrequency Guidewire Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
SoundBite® Crossing System XS Peripheral
FDA 510(k)
FDA Class 2
·Cardiovascular
Tigereye ST CTO-Crossing Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular