FDA 510(k)

TorqVue Low Profile Delivery Catheter

K-Nummer: K162228 · 2016-09-09

AntragstellerAga Medical Corporation (Wholly Owned by St.Jude Medical Cor

Entscheidungsdatum2016-09-09

ProduktcodeDQY

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

TorqVue Low Profile Delivery Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K162228. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the TorqVue Low Profile Delivery Catheter?

TorqVue Low Profile Delivery Catheter is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor. The 510(k) number is K162228.

When did TorqVue Low Profile Delivery Catheter receive FDA 510(k) clearance?

TorqVue Low Profile Delivery Catheter received FDA 510(k) clearance on 2016-09-09, under 510(k) number K162228.

Who is the listed applicant for TorqVue Low Profile Delivery Catheter?

The FDA 510(k) record lists Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TorqVue Low Profile Delivery Catheter?

The FDA product code for TorqVue Low Profile Delivery Catheter is DQY.

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Verwandte Geräte (Code: DQY)

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