I.V. Startpak Vascular Access Start Kit

FDA 510(k) K942238 · Bd Becton Dickinson Vacutainer Systems Preanalytic

Substantially Equivalent

510(k) numberK942238

Submission

Device name
I.V. Startpak Vascular Access Start Kit
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Sandy, UT, US
Received
May 9, 1994
Decision date
June 3, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LRS – I.V. Start Kit
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5200
Specialty
General Hospital

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification…

Other 510(k)s with product code LRS

510(k)DeviceApplicantDecision
K050654Amsino I.V. Start KitLRS · Traditional Amsino International, Inc.05/02/2005SE
K001879Infusion IV SetLRS · Traditional Nirvi Intl. USA11/20/2001SE
K963722IV Start KitLRS · Traditional Grand Medical Products11/27/1996SE
K951167EMS I.V. Start KitLRS · Traditional Emergency Medical Supply, Inc.05/16/1995SN
K950184B. Braun IV Start KitsLRS · Traditional B. Braun of America, Inc.03/15/1995SEKD
K944041Personal Hearing SystemLRS · Traditional Resound Corp.12/27/1994SE
K943941Safestart Vascular Access Start KitLRS · Traditional Becton Dickinson Vascular Access, Inc.10/20/1994SE
K935684IV Start KitLRS · Traditional Cush Medical Products06/10/1994SEKD
K941469IV Start KitLRS · Traditional Clinical Resources, Inc.05/12/1994SE
K925018IV Prep Kit W/O Dressing (Non-Sterile)LRS · Traditional Customed, Inc.08/27/1993SEKD

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Questions and answers

When was I.V. Startpak Vascular Access Start Kit cleared by the FDA?

I.V. Startpak Vascular Access Start Kit (K942238) received a 510(k) decision of Substantially Equivalent on June 3, 1994, 25 days after the submission was received.

What is the product code of K942238?

The FDA product code is LRS – I.V. Start Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5200.