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FDA 510(k)

Pluski Safe 1 Safety IV Catheter

K-Number: K210037 · 2022-03-25

ApplicantMediplus (India) Limited
Decision Date2022-03-25
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Pluski Safe 1 Safety IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Mediplus (India) Limited. It received FDA 510(k) clearance on 2022-03-25 under 510(k) number K210037. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pluski Safe 1 Safety IV Catheter?

Pluski Safe 1 Safety IV Catheter is a medical device that received FDA 510(k) clearance on 2022-03-25. The listed applicant is Mediplus (India) Limited. The 510(k) number is K210037.

When did Pluski Safe 1 Safety IV Catheter receive FDA 510(k) clearance?

Pluski Safe 1 Safety IV Catheter received FDA 510(k) clearance on 2022-03-25, under 510(k) number K210037.

Who is the listed applicant for Pluski Safe 1 Safety IV Catheter?

The FDA 510(k) record lists Mediplus (India) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pluski Safe 1 Safety IV Catheter?

The FDA product code for Pluski Safe 1 Safety IV Catheter is FOZ.

Related Devices (Code: FOZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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