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510(k) K941469

IV START KIT by Clinical Resources, Inc. — Product Code LRS

K941469 is an FDA 510(k) premarket notification submitted by Clinical Resources, Inc. for the device "IV START KIT". The FDA issued a decision of Substantially Equivalent on May 12, 1994. The device falls under product code LRS (I.V. Start Kit), a Class II device regulated under 21 CFR 880.5200. Clinical Resources, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1994
Date Received
March 28, 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 Clinical Resources, Inc.

  • K941470 — TRACHEOSTOMY CARE KIT (February 14, 1995)
  • K944882 — IRRIGATION TRAY (January 12, 1995)
  • K944881 — SKIN SCRUB TRAY (December 27, 1994)
  • K945019 — FLUFF GAUXZE ROLL (December 23, 1994)
  • K945021 — FLUFF GAUZE SPONGE (December 23, 1994)
  • K944879 — GAUZE SPONGES (December 23, 1994)
  • K945020 — FLUFF GAUZE SPONGE (December 23, 1994)
  • K944880 — BODILY FLUID DISPOSAL KIT (December 15, 1994)
  • K941468 — DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY (May 12, 1994)
  • K941467 — WOUND DRESSING KIT (May 12, 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)
  • 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)
  • K942238 — I.V. STARTPAK VASCULAR ACCESS START KIT (June 3, 1994)
  • K925018 — IV PREP KIT W/O DRESSING (NON-STERILE) (August 27, 1993)

FDA data resources