510(k) K942238

I.V. STARTPAK VASCULAR ACCESS START KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LRS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 3, 1994
Date Received: May 9, 1994
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: I.V. Start Kit
Device Class: Class II
Regulation Number: 880.5200
Review Panel: SU
Submission Type

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 (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

K003062 — BACTEC MGIT 960 SIR KITS (June 6, 2001)
K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (March 21, 2001)
K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (February 1, 2001)
K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
K001364 — BD DIRECTIGEN FLU A+B (June 28, 2000)
K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (April 25, 2000)
K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (April 13, 2000)
K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
K992734 — BECTON DICKINSON SYRINGE (October 1, 1999)
K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

Other clearances for product code LRS

K050654 — AMSINO I.V. START KIT (May 2, 2005)
K001879 — INFUSION IV SET (November 20, 2001)
K963722 — IV START KIT (November 27, 1996)
K951167 — EMS I.V. START KIT (May 16, 1995)
K950184 — B. BRAUN IV START KITS (March 15, 1995)
K944041 — PERSONAL HEARING SYSTEM (December 27, 1994)
K943941 — SAFESTART VASCULAR ACCESS START KIT (October 20, 1994)
K935684 — IV START KIT (June 10, 1994)
K941469 — IV START KIT (May 12, 1994)
K925018 — IV PREP KIT W/O DRESSING (NON-STERILE) (August 27, 1993)