FDA 510(k)

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set

Numéro K : K193380 · 2020-07-20

Date de décision2020-07-20

Code produitNRY

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2020-07-20 under 510(k) number K193380. 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 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set?

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2020-07-20. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K193380.

When did CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set receive FDA 510(k) clearance?

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set received FDA 510(k) clearance on 2020-07-20, under 510(k) number K193380.

Who is the listed applicant for CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set?

The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set?

The FDA product code for CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set is NRY.

Essais cliniques associés

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Autres dossiers indiquant Codman & Shurtleff, Inc. en tant que demandeur

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Dispositifs connexes (Code : NRY)

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Source officielle

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