NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE

Catheter, Embolectomy

NEXGEN MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Nexgen Medical Systems, Inc. with the FDA for Nexgen Peripheral Mechanical Retrieval Device.

Pre-market Notification Details

• Device ID: K110315
• 510k Number: K110315
• Device Name: NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE
• Classification: Catheter, Embolectomy
• Applicant: NEXGEN MEDICAL SYSTEMS, INC. 1050 W. NASA BLVD. SUITE 136 Melbourne, FL 32901
• Contact: Craig Pagan
• Correspondent: Craig Pagan; NEXGEN MEDICAL SYSTEMS, INC. 1050 W. NASA BLVD. SUITE 136 Melbourne, FL 32901
• Product Code: DXE
• CFR Regulation Number: 870.5150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-02-02
• Decision Date: 2011-10-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00855975007062	K110315	000
00855975007031	K110315	000
00855975007024	K110315	000