FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Zenith Flex System
K Number: K172167
·
Decision Apr 19, 2018
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
108
Applicant Total
9
Review Days
275
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Basic Information
- Device Name
- Zenith Flex System
- K Number
- K172167
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inneuroco, Inc.
- Date Received
- July 18, 2017
- Decision Date
- April 19, 2018
- Product Code
- NRY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | FDA class 2 | Cardiovascular |
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Other Clearances by Inneuroco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232260 | Thinline Sheath Introducer | Sep 27, 2023 | Substantially Equivalent |
| K220331 | 091 Balloon Guide Catheter | Jul 29, 2022 | Substantially Equivalent |
| K190338 | 046 Zenith Flex | Aug 2, 2019 | Substantially Equivalent |
| K181354 | 074 Zenith Flex System | Oct 25, 2018 | Substantially Equivalent |
| K173709 | Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm | Jan 26, 2018 | Substantially Equivalent |
| K172468 | 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm | Dec 6, 2017 | Substantially Equivalent |
| K171672 | 065 Zenith, 074 Zenith | Oct 19, 2017 | Substantially Equivalent |
| K161262 | Super Distal Access (SDA) | Sep 19, 2016 | Substantially Equivalent |