INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)

Set, Administration, Intravascular

MEDEX, INC.

The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Intravascular (i-v) Admininistration Set (dvgenpers Fpa).

Pre-market Notification Details

• Device ID: K952160
• 510k Number: K952160
• Device Name: INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)
• Classification: Set, Administration, Intravascular
• Applicant: MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316
• Contact: Cathy Chenetski
• Correspondent: Cathy Chenetski; MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-05-08
• Decision Date: 1995-09-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50351688509848	K952160	000
50351688509763	K952160	000
50351688509664	K952160	000
50351688509510	K952160	000
50351688509824	K952160	000
50351688509749	K952160	000
50351688505406	K952160	000
50351688505390	K952160	000