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FDA 510(k)

Introcan Safety 2 IV Catheter 18-24 gauge

K-Number: K192676 · 2020-04-01

ApplicantB.Braun Medical, Inc.
Decision Date2020-04-01
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Introcan Safety 2 IV Catheter 18-24 gauge is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2020-04-01 under 510(k) number K192676. 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 Introcan Safety 2 IV Catheter 18-24 gauge?

Introcan Safety 2 IV Catheter 18-24 gauge is a medical device that received FDA 510(k) clearance on 2020-04-01. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K192676.

When did Introcan Safety 2 IV Catheter 18-24 gauge receive FDA 510(k) clearance?

Introcan Safety 2 IV Catheter 18-24 gauge received FDA 510(k) clearance on 2020-04-01, under 510(k) number K192676.

Who is the listed applicant for Introcan Safety 2 IV Catheter 18-24 gauge?

The FDA 510(k) record lists B.Braun Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Introcan Safety 2 IV Catheter 18-24 gauge?

The FDA product code for Introcan Safety 2 IV Catheter 18-24 gauge is FOZ.

Other records listing B.Braun Medical, Inc. as applicant

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.

K253235Introcan Safety® Deep Access XL IV CatheterK243392Infusomat® Space Volumetric Infusion Pump Administration SetsK240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemK241845Introcan Safety® 2 IV CatheterK241385Omnifix Syringe NRFitK231242Perifix FX Catheter; Contiplex FX Catheter

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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

View on FDA Database →

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

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