I.V. STARTPAK VASCULAR ACCESS START KIT

I.v. Start Kit

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for I.v. Startpak Vascular Access Start Kit.

Pre-market Notification Details

• Device ID: K942238
• 510k Number: K942238
• Device Name: I.V. STARTPAK VASCULAR ACCESS START KIT
• Classification: I.v. Start Kit
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 9450 SOUTH STATE SREET Sandy, UT 84070
• Contact: C.j. Welle
• Correspondent: C.j. Welle; BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 9450 SOUTH STATE SREET Sandy, UT 84070
• Product Code: LRS
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-05-09
• Decision Date: 1994-06-03