FDA 510(k)

Distal Access Catheter

K-Number: K231218 · 2024-01-19

Decision Date2024-01-19

Product CodeQJP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Distal Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Accumedical Beijing , Ltd.. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K231218. 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 Distal Access Catheter?

Distal Access Catheter is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Accumedical Beijing , Ltd.. The 510(k) number is K231218.

When did Distal Access Catheter receive FDA 510(k) clearance?

Distal Access Catheter received FDA 510(k) clearance on 2024-01-19, under 510(k) number K231218.

Who is the listed applicant for Distal Access Catheter?

The FDA 510(k) record lists Accumedical Beijing , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Distal Access Catheter?

The FDA product code for Distal Access Catheter is QJP.

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, LLC K253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker Neurovascular K261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo Neuro K261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro K253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

Official Source

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