speX Support Catheter
FDA 510(k) K173662 · Reflow Medical, Inc.
510(k) numberK173662
Submission
- Device name
- speX Support Catheter
- Applicant
- Reflow Medical, Inc.
San Clemente, CA, US - Received
- November 29, 2017
- Decision date
- December 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| 510(k) | Device | Decision |
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| K262013 | Kiba CTO Crossing CatheterPDU · Special | 08/28/2026SE |
| K251277 | CoraForce Microcatheter, CoraFlex MicrocatheterDQY · Special | 08/22/2025SE |
| K233350 | SINC Support CatheterDQY · Traditional | 02/08/2024SE |
| K210188 | coraCrossDQY · Special | 05/28/2021SE |
| K201811 | coraForce and coraFlex Support CathetersDQY · Traditional | 10/26/2020SE |
| K200094 | speX LP Support CatheterDQY · Special | 03/18/2020SE |
| K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35DQY · Traditional | 02/20/2020SE |
| K193012 | speX Support CatheterDQY · Traditional | 02/19/2020SE |
| K190393 | Wingman 14C Crossing CatheterDQY · Special | 05/09/2019SE |
| K173661 | Wingman 35 Crossing CatheterDQY · Traditional | 04/18/2018SE |
Questions and answers
When was speX Support Catheter cleared by the FDA?
speX Support Catheter (K173662) received a 510(k) decision of Substantially Equivalent on December 20, 2017, 21 days after the submission was received.
What is the product code of K173662?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.