FDA 510(k)

Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set

Numéro K : K233329 · 2024-04-23

Date de décision2024-04-23

Code produitNRY

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2024-04-23 under 510(k) number K233329. 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 Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set?

Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2024-04-23. The listed applicant is Route 92 Medical, Inc.. The 510(k) number is K233329.

When did Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set receive FDA 510(k) clearance?

Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set received FDA 510(k) clearance on 2024-04-23, under 510(k) number K233329.

Who is the listed applicant for Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set?

The FDA 510(k) record lists Route 92 Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set?

The FDA product code for Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set is NRY.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Autres dossiers indiquant Route 92 Medical, Inc. en tant que demandeur

K260220Route 92 Medical Full Length 046 Access System K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set K2405298F Modified Sheath System K231583Route 92 Medical Full Length 054 Access System K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set K222743Route 92 Medical Full Length 070 Access System

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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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