MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

LUTHER NEEDLESAFE PRODUCTS, INC.

The following data is part of a premarket notification filed by Luther Needlesafe Products, Inc. with the FDA for Mini-midline Extended Dwell Safety Catheter.

Pre-market Notification Details

• Device ID: K130518
• 510k Number: K130518
• Device Name: MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: LUTHER NEEDLESAFE PRODUCTS, INC. 7 RIMANI DRIVE Mission Viejo, CA 92692
• Contact: Rebecca K Pine
• Correspondent: Rebecca K Pine; LUTHER NEEDLESAFE PRODUCTS, INC. 7 RIMANI DRIVE Mission Viejo, CA 92692
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-02-27
• Decision Date: 2013-04-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850017259058	K130518	000
10850017259048	K130518	000
10850017259031	K130518	000
10850017259024	K130518	000
10850017259017	K130518	000
10850017259000	K130518	000