MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR

Set, Administration, Intravascular

CAREFUSION

The following data is part of a premarket notification filed by Carefusion with the FDA for Maxzero Extension Set With Needless Connector.

Pre-market Notification Details

• Device ID: K140831
• 510k Number: K140831
• Device Name: MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
• Classification: Set, Administration, Intravascular
• Applicant: CAREFUSION 10020 PACIFIC MESA BLVD San Diego, CA 92121
• Contact: Larry Walker
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2014-04-02
• Decision Date: 2014-04-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20885403230544	K140831	000
20885403240727	K140831	000
20885403240734	K140831	000
20885403240741	K140831	000
20885403240758	K140831	000
20885403240765	K140831	000
20885403240772	K140831	000
20885403240789	K140831	000
20885403240796	K140831	000
20885403240802	K140831	000
20885403240628	K140831	000
50885403230668	K140831	000
50885403230644	K140831	000
20885403230551	K140831	000
20885403230568	K140831	000
20885403230575	K140831	000
20885403230582	K140831	000
20885403230599	K140831	000
20885403230605	K140831	000
50885403230613	K140831	000
20885403230629	K140831	000
50885403230637	K140831	000
20885403240819	K140831	000
50885403240834	K140831	000
50885403240841	K140831	000
50885403418134	K140831	000
50885403418141	K140831	000
50885403418158	K140831	000
50885403423367	K140831	000
50885403426511	K140831	000
50885403427228	K140831	000
50885403427235	K140831	000
50885403427242	K140831	000
50885403427259	K140831	000
50885403418127	K140831	000
50885403417915	K140831	000
50885403417908	K140831	000
50885403240858	K140831	000
20885403242080	K140831	000
20885403242097	K140831	000
50885403417847	K140831	000
50885403417854	K140831	000
50885403417861	K140831	000
50885403417878	K140831	000
50885403417885	K140831	000
50885403417892	K140831	000
50885403427266	K140831	000