INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE

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

BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.

The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems, Inc. with the FDA for Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima, And Saf-t-intima Intravascular Cathete.

Pre-market Notification Details

• Device ID: K013800
• 510k Number: K013800
• Device Name: INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070
• Contact: Leslie Wood
• Correspondent: Leslie Wood; BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-11-15
• Decision Date: 2001-12-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50382903822879	K013800	000
50382903822770	K013800	000
50382903822695	K013800	000
50382903822688	K013800	000
50382903822596	K013800	000
50382903822589	K013800	000