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FDA 510(k)

Esperance Distal Access Catheter

K-Number: K231056 · 2024-03-08

ApplicantWallaby Medical
Decision Date2024-03-08
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Esperance Distal Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Wallaby Medical. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K231056. 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 Esperance Distal Access Catheter?

Esperance Distal Access Catheter is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Wallaby Medical. The 510(k) number is K231056.

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

Esperance Distal Access Catheter received FDA 510(k) clearance on 2024-03-08, under 510(k) number K231056.

Who is the listed applicant for Esperance Distal Access Catheter?

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

What is the FDA product code for Esperance Distal Access Catheter?

The FDA product code for Esperance Distal Access Catheter is QJP.

Other records listing Wallaby Medical 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.

K240917Esperance 3+ Aspiration Catheter SystemK232437Paragon 8F Balloon Guide CatheterK223139Wallaby 017 Micro CatheterK2226036F Wallaby Long SheathK211697Esperance Aspiration Catheter SystemK173711Wallaby Avenir Coil System

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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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