FDA 510(k)

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

Numéro K : K243418 · 2024-12-02

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

Date de décision2024-12-02

Code produitJCX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular en tant que demandeur

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Dispositifs connexes (Code : 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 K182950Unit de suction AcareAcare Technology Co., Ltd.

Source officielle

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