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FDA 510(k)

Introcan Safety® Deep Access XL IV Catheter

K-Number: K253235 · 2026-05-15

ApplicantB.Braun Medical, Inc.
Decision Date2026-05-15
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Introcan Safety® Deep Access XL IV Catheter 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 2026-05-15 under 510(k) number K253235. 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® Deep Access XL IV Catheter?

Introcan Safety® Deep Access XL IV Catheter is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K253235.

When did Introcan Safety® Deep Access XL IV Catheter receive FDA 510(k) clearance?

Introcan Safety® Deep Access XL IV Catheter received FDA 510(k) clearance on 2026-05-15, under 510(k) number K253235.

Who is the listed applicant for Introcan Safety® Deep Access XL IV Catheter?

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® Deep Access XL IV Catheter?

The FDA product code for Introcan Safety® Deep Access XL IV Catheter 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.

K243392Infusomat® 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 CatheterK223479AQUAbase nX

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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, LLCK252137BD 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 LimitedK252398SURFLO Hybria Closed System Safety IV CatheterTerumo Medical Products (Hangzhou) Co., Ltd.

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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