FDA 510(k)

Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing

Número K: K243418 · 2024-12-02

RequerenteMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

Data da decisão2024-12-02

Código do produtoJCX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2024-12-02 under 510(k) number K243418. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing?

Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing is a medical device that received FDA 510(k) clearance on 2024-12-02. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K243418.

When did Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing receive FDA 510(k) clearance?

Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing received FDA 510(k) clearance on 2024-12-02, under 510(k) number K243418.

Who is the listed applicant for Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing?

The FDA product code for Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing is JCX.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Micro Therapeutics, Inc. d/b/a ev3 Neurovascular como candidato(a)

K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter K243080Riptide Aspiration System K211990Rist 071 Radial Access Guide Catheter K203432Axium Detachable Coil; Axium Prime Detachable Coil K203358Solitaire X Revascularization Device K202850Concerto Versa, Detachable Coil

Ver todos os 27 dispositivos →

Dispositivos Relacionados (Código: JCX)

K250964Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow Aspiration Pump (MVFLOWPMP01)Microvention K251111CaryExcitus AS K233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,Ltd K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)Stryker Instruments K182950Acare Suction UnitAcare Technology Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.