046 Zenith Flex
FDA 510(k) K190338 · Inneuroco, Inc.
510(k) numberK190338
Submission
- Device name
- 046 Zenith Flex
- Applicant
- Inneuroco, Inc.
Sunrise, FL, US - Received
- February 14, 2019
- Decision date
- August 2, 2019
- 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.
Other 510(k)s with product code NRY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260617 | Tigertriever 13 Ultra Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 08/28/2026SE |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setNRY · Special | CERENOVUS, Inc. | 08/13/2026SE |
| K262399 | Millipede SystemNRY · Special | Perfuze, Ltd. | 08/12/2026SE |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration TubingNRY · Special | Alembic, LLC | 08/12/2026SE |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter)NRY · Traditional | Scientia Vascular, Inc. | 07/16/2026SE |
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing)NRY · Traditional | Penumbra, Inc. | 06/10/2026SE |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing SetNRY · Traditional | Suzhou Zenith Vascular SciTech Limited | 05/20/2026SE |
| K254276 | Lynx Aspiration Catheter SystemNRY · Traditional | QApel Medical, Inc. | 05/07/2026SE |
| K253590 | Millipede SystemNRY · Traditional | Perfuze, Ltd. | 03/16/2026SE |
| K253062 | Tigertriever 25 Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 03/12/2026SE |
More from Rapid Medical Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K232260 | Thinline Sheath IntroducerDYB · Traditional | 09/27/2023SE |
| K220331 | 091 Balloon Guide CatheterDQY · Traditional | 07/29/2022SE |
| K181354 | 074 Zenith Flex SystemNRY · Traditional | 10/25/2018SE |
| K172167 | Zenith Flex SystemNRY · Traditional | 04/19/2018SE |
| 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 046 Zenith Flex cleared by the FDA?
046 Zenith Flex (K190338) received a 510(k) decision of Substantially Equivalent on August 2, 2019, 169 days after the submission was received.
What is the product code of K190338?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.