FDA 510(k)

Amplatzer Trevisio Intravascular Delivery System

K-Number: K190581 · 2019-04-05

Decision Date2019-04-05

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Amplatzer Trevisio Intravascular Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2019-04-05 under 510(k) number K190581. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Amplatzer Trevisio Intravascular Delivery System?

Amplatzer Trevisio Intravascular Delivery System is a medical device that received FDA 510(k) clearance on 2019-04-05. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K190581.

When did Amplatzer Trevisio Intravascular Delivery System receive FDA 510(k) clearance?

Amplatzer Trevisio Intravascular Delivery System received FDA 510(k) clearance on 2019-04-05, under 510(k) number K190581.

Who is the listed applicant for Amplatzer Trevisio Intravascular Delivery System?

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

What is the FDA product code for Amplatzer Trevisio Intravascular Delivery System?

The FDA product code for Amplatzer Trevisio Intravascular Delivery System is DQY.

Other records listing ABBOTT MEDICAL as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P910023Implantable cardioverter defibrillator (non-CRT)PMA P160054Ventricular (assist) bypass PMA P060040Ventricular (assist) bypass PMA P030054Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)PMA P250022Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation PMA P040021heart-valve, non-allograft tissue

View all 91 devices →

Related Devices (Code: DQY)

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLC K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott K261631Amplatzer TorqVue Exchange SystemAbbott Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.