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510(k) K950184

B. BRAUN IV START KITS by B. Braun of America, Inc. — Product Code LRS

K950184 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "B. BRAUN IV START KITS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 15, 1995. The device falls under product code LRS (I.V. Start Kit), a Class II device regulated under 21 CFR 880.5200. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 15, 1995
Date Received
January 17, 1995
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 B. Braun of America, Inc.

  • K993024 — CELSITE IMPLANTABLE PORT WITH VALVED CATHETER (March 13, 2000)
  • K983794 — CHEMO MINI SPIKE PLUS (March 23, 1999)
  • K946170 — COMFORT-Q SUBCUTANEOUS INJECTION SETS (November 3, 1995)
  • K945850 — BRAUN DIACAN(R) FISTULA NEEDLES (October 6, 1995)
  • K942988 — FILTERED EXTENSION SETS (July 14, 1995)
  • K945752 — CELSITE(TM) BRACHIAL VENOUS PORT (May 31, 1995)
  • K945551 — CELSITE(TM) DUAL VENOUS SYSTEM (April 21, 1995)
  • K943770 — LOW VOLUME MULTIPORT (April 10, 1995)
  • K950982 — B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE (April 4, 1995)
  • K943181 — DISPENSING PIN WITH ONE-WAY VALVE (September 29, 1994)

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)
  • K944041 — PERSONAL HEARING SYSTEM (December 27, 1994)
  • K943941 — SAFESTART VASCULAR ACCESS START KIT (October 20, 1994)
  • K935684 — IV START KIT (June 10, 1994)
  • K942238 — I.V. STARTPAK VASCULAR ACCESS START KIT (June 3, 1994)
  • K941469 — IV START KIT (May 12, 1994)
  • K925018 — IV PREP KIT W/O DRESSING (NON-STERILE) (August 27, 1993)

FDA data resources