Wingman 14, Wingman 14C, Wingman 18, Wingman 35
FDA 510(k) K193596 · Reflow Medical
510(k) numberK193596
Submission
- Device name
- Wingman 14, Wingman 14C, Wingman 18, Wingman 35
- Applicant
- Reflow Medical
San Clemente, CA, US - Received
- December 23, 2019
- Decision date
- February 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| 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 |
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Questions and answers
When was Wingman 14, Wingman 14C, Wingman 18, Wingman 35 cleared by the FDA?
Wingman 14, Wingman 14C, Wingman 18, Wingman 35 (K193596) received a 510(k) decision of Substantially Equivalent on February 20, 2020, 59 days after the submission was received.
What is the product code of K193596?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.