510(k) K162253

Trapper Exchange Device by Creganna Medical Aslo Business AS Cregganna Tactx Medical — Product Code DQY

K162253 is an FDA 510(k) premarket notification submitted by Creganna Medical Aslo Business AS Cregganna Tactx Medical for the device "Trapper Exchange Device". The FDA issued a decision of Substantially Equivalent on Jan 6, 2017. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Creganna Medical Aslo Business AS Cregganna Tactx Medical has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 6, 2017
Date Received
Aug 10, 2016
Clearance Type
Traditional
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
510(k)