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510(k) Data Aggregation
K Number
K210037Device Name
Pluski Safe 1 Safety IV Catheter
Manufacturer
Date Cleared
2022-03-25
(443 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Mediplus (India) Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Pluski Safe 1 Safety IV Catheter is Passive anti-needle stick device for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14-22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.
Device Description
Pluski Safe 1 Safety I.V. Catheter is a medical device used for inserting a catient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. The device is equipped with a safety feature intended to prevent needle stick injuries. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids and have hence been potentially contaminated with infectious agents.
The device contains different parts like Needle cover, Catheter holder, body, Cross clip safety & filterHub cover. Devices are available in winged and non-winged version.
These devices are sold in sterile form & are single use devices.
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