I.V. Starr Kit

FDA 510(k) K912161 · Medical Device Inspection Co., Inc.

Substantially Equivalent

510(k) numberK912161

Submission

Device name
I.V. Starr Kit
Applicant
Medical Device Inspection Co., Inc.
Great Neck, NY, US
Received
May 16, 1991
Decision date
October 8, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LKB – Pad, Alcohol, Device Disinfectant
Device class
Unclassified

Other 510(k)s with product code LKB

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K132380Prevantics Device SwabLKB · Traditional Professional Disposables International, Inc.08/27/2014SE
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K112791Sitescrub Ipa DeviceLKB · Traditional C. R. Bard02/24/2012SE
K912731Steri-SwabLKB · Traditional Westlock Investments (Usa), Inc.10/02/1991SE
K910735Hexidis Alcohol SwabLKB · Traditional Specialites Septodont04/02/1991SE
K896898Bowen Electrode Skin Prepatory CleanserLKB · Traditional Bowen & Company, Inc.04/04/1990SE
K896835Alcohol Prep and Povidone-Iodine PrepLKB · Traditional Norpak Mfg., Inc.01/11/1990SE
K894791Baxter Acetone-Alcohol Swabstick, SterileLKB · Traditional Span-America Medical Systems, Inc.10/03/1989SE
K893958Baxter Acetone-Alcohol Prep Pads, SterileLKB · Traditional Span-America Medical Systems, Inc.10/03/1989SE
K892193Quickpad (Alcohol Swabs)LKB · Traditional Holtsch Co., Inc.08/04/1989SE

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K922045Shower ChairsINM · Traditional 05/26/1992SE
K912075C-Section TrayKNA · Traditional 04/07/1992SESK
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Questions and answers

When was I.V. Starr Kit cleared by the FDA?

I.V. Starr Kit (K912161) received a 510(k) decision of Substantially Equivalent on October 8, 1991, 145 days after the submission was received.

What is the product code of K912161?

The FDA product code is LKB – Pad, Alcohol, Device Disinfectant, a Unclassified device.