510(k) K120178

WINGMAN EXTENDABLE TIP SUPPORT CATHETER by Reflow Medical — Product Code DQY

K120178 is an FDA 510(k) premarket notification submitted by Reflow Medical for the device "WINGMAN EXTENDABLE TIP SUPPORT CATHETER". The FDA issued a decision of Substantially Equivalent on February 8, 2012. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Reflow Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2012
Date Received
January 20, 2012
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