Wingman 14C Crossing Catheter
FDA 510(k) K190393 · Reflow Medical, Inc.
510(k) numberK190393
Submission
- Device name
- Wingman 14C Crossing Catheter
- Applicant
- Reflow Medical, Inc.
San Clemente, CA, US - Received
- February 19, 2019
- Decision date
- May 9, 2019
- 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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Questions and answers
When was Wingman 14C Crossing Catheter cleared by the FDA?
Wingman 14C Crossing Catheter (K190393) received a 510(k) decision of Substantially Equivalent on May 9, 2019, 79 days after the submission was received.
What is the product code of K190393?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.