FDA 510(k)

Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device

Numéro K : K230429 · 2023-04-17

Date de décision2023-04-17

Code produitNRY

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Medical , Ltd.. It received FDA 510(k) clearance on 2023-04-17 under 510(k) number K230429. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device?

Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device is a medical device that received FDA 510(k) clearance on 2023-04-17. The listed applicant is Rapid Medical , Ltd.. The 510(k) number is K230429.

When did Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device receive FDA 510(k) clearance?

Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device received FDA 510(k) clearance on 2023-04-17, under 510(k) number K230429.

Who is the listed applicant for Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device?

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

What is the FDA product code for Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device?

The FDA product code for Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device is NRY.

Essais cliniques associés

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Autres dossiers indiquant Rapid Medical , Ltd. en tant que demandeur

K253146Hyperdrive 35 Guidewire K260617Tigertriever 13 Ultra Revascularization Device K254006Drivewire 35 Guidewire K253062Tigertriever 25 Revascularization Device K251603Tigertriever 17 Ultra Revascularization Device K233791Drivewire 24 Guidewire

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Dispositifs connexes (Code : NRY)

K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing KitMaduro Medical, Inc.K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd.K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.

Source officielle

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