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FDA 510(k)

Anchor Dual Lumen Guidewire Catheter

K-Number: K201076 · 2020-08-06

ApplicantAqure Medical, Inc.
Decision Date2020-08-06
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Anchor Dual Lumen Guidewire Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Aqure Medical, Inc.. It received FDA 510(k) clearance on 2020-08-06 under 510(k) number K201076. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anchor Dual Lumen Guidewire Catheter?

Anchor Dual Lumen Guidewire Catheter is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Aqure Medical, Inc.. The 510(k) number is K201076.

When did Anchor Dual Lumen Guidewire Catheter receive FDA 510(k) clearance?

Anchor Dual Lumen Guidewire Catheter received FDA 510(k) clearance on 2020-08-06, under 510(k) number K201076.

Who is the listed applicant for Anchor Dual Lumen Guidewire Catheter?

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

What is the FDA product code for Anchor Dual Lumen Guidewire Catheter?

The FDA product code for Anchor Dual Lumen Guidewire Catheter is QJP.

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.

NCT06668766Single Lumen Midline Catheter vs Long Peripheral Intravenous Cather for Difficult Intravenous Access in the EDCOMPLETED

Related Devices (Code: QJP)

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.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech 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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