FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tigereye CTO-Crossing Catheter
K Number: K201330
·
Decision Sep 10, 2020
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
56
Applicant Total
25
Review Days
114
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Basic Information
- Device Name
- Tigereye CTO-Crossing Catheter
- K Number
- K201330
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avinger, Inc.
- Date Received
- May 19, 2020
- Decision Date
- September 10, 2020
- 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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Other Clearances by Avinger, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K230005 | Pantheris LV Atherectomy Catheter | Jun 6, 2023 | Substantially Equivalent |
| K230594 | Tigereye ST CTO-Crossing Catheter | Apr 25, 2023 | Substantially Equivalent |
| K212468 | Tigereye CTO-Crossing Catheter | Jan 6, 2022 | Substantially Equivalent |
| K212047 | Pantheris System | Nov 16, 2021 | Substantially Equivalent |
| K182341 | Pantheris SV | Apr 9, 2019 | Substantially Equivalent |
| K173862 | Pantheris System | May 22, 2018 | Substantially Equivalent |
| K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled | Oct 30, 2017 | Substantially Equivalent |
| K163264 | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled | Dec 21, 2016 | Substantially Equivalent |
| K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled | Oct 18, 2016 | Substantially Equivalent |
| K160827 | Pantheris Catheter | Apr 21, 2016 | Substantially Equivalent |