510(k) K173709

Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm by Inneuroco, Inc. — Product Code DQY

K173709 is an FDA 510(k) premarket notification submitted by Inneuroco, Inc. for the device "Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm". The FDA issued a decision of Substantially Equivalent on January 26, 2018. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Inneuroco, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2018
Date Received
December 4, 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