NU-SITE

Set, Administration, Intravascular

MEDEX, INC.

The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Nu-site.

Pre-market Notification Details

• Device ID: K943897
• 510k Number: K943897
• Device Name: NU-SITE
• Classification: Set, Administration, Intravascular
• Applicant: MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026
• Contact: Cathy Chenetski
• Correspondent: Cathy Chenetski; MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-08-10
• Decision Date: 1995-02-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50351688500685	K943897	000