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FDA 510(k)

Introcan Safety 3 Closed IV Catheter

K-Number: K163358 · 2017-04-28

ApplicantB.Braun Melsungen AG
Decision Date2017-04-28
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Introcan Safety 3 Closed IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Melsungen AG. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K163358. 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 3 Closed IV Catheter?

Introcan Safety 3 Closed IV Catheter is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is B.Braun Melsungen AG. The 510(k) number is K163358.

When did Introcan Safety 3 Closed IV Catheter receive FDA 510(k) clearance?

Introcan Safety 3 Closed IV Catheter received FDA 510(k) clearance on 2017-04-28, under 510(k) number K163358.

Who is the listed applicant for Introcan Safety 3 Closed IV Catheter?

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

What is the FDA product code for Introcan Safety 3 Closed IV Catheter?

The FDA product code for Introcan Safety 3 Closed IV Catheter is FOZ.

Related Clinical Trials

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.

NCT02460042Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)COMPLETEDNCT04470934SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)ACTIVE_NOT_RECRUITINGNCT07363161BASel Kosten-Effektivitäts-Trial: Drug-coated BALLoon (DCB) vs. Drug-eluting Stent (DES) Strategy in High-risk Patients With Coronary Artery Disease (CAD)RECRUITING

Other records listing B.Braun Melsungen AG 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.

K152050Pencylcap

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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