510(k) K171146

Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. by Arrow International, Inc. (Subsidiary Of Telelflex Inc.) — Product Code DQY

K171146 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. (Subsidiary Of Telelflex Inc.) for the device "Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.". The FDA issued a decision of Substantially Equivalent on Jun 23, 2017. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 23, 2017
Date Received
Apr 19, 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
510(k)