Riptide Aspiration System

Catheter, Thrombus Retriever

Micro Therapeutics, Inc., D/b/a Ev3 Neurovascular

The following data is part of a premarket notification filed by Micro Therapeutics, Inc., D/b/a Ev3 Neurovascular with the FDA for Riptide Aspiration System.

Pre-market Notification Details

• Device ID: K172448
• 510k Number: K172448
• Device Name: Riptide Aspiration System
• Classification: Catheter, Thrombus Retriever
• Applicant: Micro Therapeutics, Inc., D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618
• Contact: Ryan Kenney
• Correspondent: Ryan Kenney; Micro Therapeutics, Inc., D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618
• Product Code: NRY
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-14
• Decision Date: 2017-12-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00847536029118	K172448	000
00847536029101	K172448	000
00847536029095	K172448	000
00763000299422	K172448	000
00763000299415	K172448	000