510(k) K173662
K173662 is an FDA 510(k) premarket notification submitted by Reflow Medical, Inc. for the device "speX Support Catheter". The FDA issued a decision of Substantially Equivalent on December 20, 2017. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Reflow Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2017
- Date Received
- November 29, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type