MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM

Catheter, Intravascular Occluding, Temporary

MICRO THERAPEUTICS, INC.

The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Modification To Hyperglide Occlusion Balloon System.

Pre-market Notification Details

• Device ID: K021066
• 510k Number: K021066
• Device Name: MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
• Classification: Catheter, Intravascular Occluding, Temporary
• Applicant: MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618
• Contact: Tom Daughters
• Correspondent: Tom Daughters; MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618
• Product Code: MJN
• CFR Regulation Number: 870.4450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-04-02
• Decision Date: 2002-06-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00836462004177	K021066	000
00836462004146	K021066	000
00836462004122	K021066	000
00836462004115	K021066	000