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Esperance Aspiration Catheter System

by Wallaby Medical 510(k)

Active United States

510(k) K211697

Overview

The Esperance Aspiration Catheter System is a catheter, thrombus retriever designed for mechanical removal of thrombi in coronary arteries. It employs a multi-segment polymer construction to facilitate precise navigation, stability, and effective aspiration of clots during percutaneous coronary interventions. The device is engineered to enhance recanalization success while minimizing vessel trauma.

This system is supplied as a single-use device, intended for use in interventional cardiology settings. It includes a 5F or 6F catheter with distinct distal (15 cm ultra-soft), middle (11 cm transition), and proximal (nylon support) segments to optimize maneuverability and structural integrity. The Esperance Aspiration Catheter System holds FDA 510(k) clearance (K211697) under the Cardiovascular advisory committee classification and is classified as a Class II medical device (regulation number 870.1250).

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211697 Date16 Nov 2021ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
NRY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Esperance Aspiration Catheter System used for?

    The Esperance Aspiration Catheter System is designed specifically for mechanical removal of thrombi (blood clots) within coronary arteries during percutaneous coronary interventions (PCI). Its multi-segment polymer construction—featuring ultra-soft distal, transition middle, and nylon-supported proximal segments—enhances navigation, stability, and effective clot aspiration while minimizing damage to the vessel walls.

  • How is the Esperance Aspiration Catheter System supplied?

    The system is supplied as a single-use device, including either a 5F or 6F catheter with distinct segmented construction. This design ensures optimal maneuverability and structural integrity for precise thrombus retrieval in interventional cardiology procedures.

  • Is the Esperance Aspiration Catheter System sterile?

    Yes, the Esperance Aspiration Catheter System is intended for single-use only, which inherently ensures sterility for each procedure. The device is packaged and sterilized by the manufacturer to meet medical device standards before distribution.

  • What sizes/models are available for the Esperance Aspiration Catheter System?

    The system is available in two primary catheter sizes: 5F and 6F. Both sizes feature the same segmented design—15 cm ultra-soft distal segment, 11 cm transition segment, and a nylon-supported proximal segment—to balance flexibility and rigidity for effective thrombus removal.

  • How should the Esperance Aspiration Catheter System be stored?

    The device should be stored in its original, unopened packaging to maintain sterility and integrity. It should be kept in a clean, dry environment, protected from extreme temperatures, direct sunlight, and physical damage. Follow manufacturer guidelines for expiration dates and storage conditions.