Zenith Flex System
FDA 510(k) K172167 · Inneuroco, Inc.
510(k) numberK172167
Submission
- Device name
- Zenith Flex System
- Applicant
- Inneuroco, Inc.
Sunrise, FL, US - Received
- July 18, 2017
- Decision date
- April 19, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRY – Catheter, Thrombus Retriever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
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| 510(k) | Device | Decision |
|---|---|---|
| K232260 | Thinline Sheath IntroducerDYB · Traditional | 09/27/2023SE |
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| K181354 | 074 Zenith Flex SystemNRY · Traditional | 10/25/2018SE |
| K173709 | Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmDQY · Special | 01/26/2018SE |
| K172468 | 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmDQY · Traditional | 12/06/2017SE |
| K171672 | 065 Zenith, 074 ZenithDQY · Traditional | 10/19/2017SE |
| K161262 | Super Distal Access (SDA)DQY · Traditional | 09/19/2016SE |
Questions and answers
When was Zenith Flex System cleared by the FDA?
Zenith Flex System (K172167) received a 510(k) decision of Substantially Equivalent on April 19, 2018, 275 days after the submission was received.
What is the product code of K172167?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.