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FDA 510(k)

Esperance Aspiration Catheter System

K-Number: K211697 · 2021-11-16

ApplicantWallaby Medical
Decision Date2021-11-16
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Esperance Aspiration Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Wallaby Medical. It received FDA 510(k) clearance on 2021-11-16 under 510(k) number K211697. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Esperance Aspiration Catheter System?

Esperance Aspiration Catheter System is a medical device that received FDA 510(k) clearance on 2021-11-16. The listed applicant is Wallaby Medical. The 510(k) number is K211697.

When did Esperance Aspiration Catheter System receive FDA 510(k) clearance?

Esperance Aspiration Catheter System received FDA 510(k) clearance on 2021-11-16, under 510(k) number K211697.

Who is the listed applicant for Esperance Aspiration Catheter System?

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 Aspiration Catheter System?

The FDA product code for Esperance Aspiration Catheter System is NRY.

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 SystemK231056Esperance Distal Access CatheterK232437Paragon 8F Balloon Guide CatheterK223139Wallaby 017 Micro CatheterK2226036F Wallaby Long SheathK173711Wallaby Avenir Coil System

View all 7 devices →

Related Devices (Code: NRY)

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.

K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou 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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