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510(k) Data Aggregation
K Number
K170112Device Name
IMD's Lumbar Puncture Needle
Manufacturer
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD)
Date Cleared
2018-02-02
(386 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMD's Lumbar Puncture Needle, a single patient use needle; it is intended to gain entry into or puncture the spinal cavity permitting injecting (including anesthesia) / withdrawl of fluids for purpose of diagnostic lumbar puncture, myelography discography procedures.
The device is intended for adult and pediatric patients.
It is to be used only under the direction of a licensed clinician.
Device Description
The IMD Inc. Lumbar Puncture Needle shares major similarities with the predicate device(s), in as much as the configuration, materials, area of use, and are identical to the IMD reference devices.
It consists of an introducer, stylet, and pencil-point needle, with plastic hubs, and stainless steel cannula. Offered in 18-27 gauges, and 3.5 in. (90 mm) and 5.0 in (124 mm) lengths.
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