510(k) K161986

SIDEKICK and USHER Support Catheters by Bard Peripheral Vascular, Inc. — Product Code DQY

K161986 is an FDA 510(k) premarket notification submitted by Bard Peripheral Vascular, Inc. for the device "SIDEKICK and USHER Support Catheters". The FDA issued a decision of Substantially Equivalent on August 4, 2016. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Bard Peripheral Vascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2016
Date Received
July 19, 2016
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