FDA 510(k)

SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands

Numéro K : K212977 · 2022-02-17

Date de décision2022-02-17

Code produitDQO

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corporation. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K212977. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands?

SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Cordis Corporation. The 510(k) number is K212977.

When did SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands receive FDA 510(k) clearance?

SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands received FDA 510(k) clearance on 2022-02-17, under 510(k) number K212977.

Who is the listed applicant for SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands?

The FDA 510(k) record lists Cordis Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands?

The FDA product code for SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands is DQO.

Essais cliniques associés

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Source officielle

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