FDA 510(k)

Attain Assist CS Access Catheter

Numéro K : K171819 · 2018-01-04

DemandeurCreganna Medical Also Doing Business AS Ceganna Tactx Medica

Date de décision2018-01-04

Code produitDQY

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Attain Assist CS Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Creganna Medical Also Doing Business AS Ceganna Tactx Medica. It received FDA 510(k) clearance on 2018-01-04 under 510(k) number K171819. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Attain Assist CS Access Catheter?

Attain Assist CS Access Catheter is a medical device that received FDA 510(k) clearance on 2018-01-04. The listed applicant is Creganna Medical Also Doing Business AS Ceganna Tactx Medica. The 510(k) number is K171819.

When did Attain Assist CS Access Catheter receive FDA 510(k) clearance?

Attain Assist CS Access Catheter received FDA 510(k) clearance on 2018-01-04, under 510(k) number K171819.

Who is the listed applicant for Attain Assist CS Access Catheter?

The FDA 510(k) record lists Creganna Medical Also Doing Business AS Ceganna Tactx Medica as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Attain Assist CS Access Catheter?

The FDA product code for Attain Assist CS Access Catheter is DQY.

Essais cliniques associés

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Dispositifs connexes (Code : DQY)

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Source officielle

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