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FDA 510(k)

Extroducer Infusion Catheter System

K-Number: K213442 · 2022-06-10

ApplicantSmartWise Sweden AB
Decision Date2022-06-10
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Extroducer Infusion Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is SmartWise Sweden AB. It received FDA 510(k) clearance on 2022-06-10 under 510(k) number K213442. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Extroducer Infusion Catheter System?

Extroducer Infusion Catheter System is a medical device that received FDA 510(k) clearance on 2022-06-10. The listed applicant is SmartWise Sweden AB. The 510(k) number is K213442.

When did Extroducer Infusion Catheter System receive FDA 510(k) clearance?

Extroducer Infusion Catheter System received FDA 510(k) clearance on 2022-06-10, under 510(k) number K213442.

Who is the listed applicant for Extroducer Infusion Catheter System?

The FDA 510(k) record lists SmartWise Sweden AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Extroducer Infusion Catheter System?

The FDA product code for Extroducer Infusion Catheter System is KRA.

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.

NCT07575191Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic CancerRECRUITING

Related Devices (Code: KRA)

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.

K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech LimitedK231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLCK231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, Inc.

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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