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