FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Viatrac 14 Plus Peripheral Dilatation Catheter
K Number: K221057
·
Decision May 5, 2022
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
30
Review Days
24
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Basic Information
- Device Name
- Viatrac 14 Plus Peripheral Dilatation Catheter
- K Number
- K221057
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Vascular
- Date Received
- April 11, 2022
- Decision Date
- May 5, 2022
- 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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| K173795 | HI-TORQUE TurnTrac Guide Wire Family | Jan 12, 2018 | Substantially Equivalent |
| K172394 | Steerable Guide Catheter | Sep 6, 2017 | Substantially Equivalent |
| K172073 | Hi-Torque Command 18 Guide Wire | Aug 25, 2017 | Substantially Equivalent |
| K161985 | Steerable Guide Catheter | Aug 7, 2016 | Substantially Equivalent |