FDA 510(k)

VASOVIEW HemoPro Endoscopic Vessel Harvesting System

Numéro K : K153194 · 2016-04-19

Date de décision2016-04-19

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

VASOVIEW HemoPro Endoscopic Vessel Harvesting System is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiovascular, LLC. It received FDA 510(k) clearance on 2016-04-19 under 510(k) number K153194. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the VASOVIEW HemoPro Endoscopic Vessel Harvesting System?

VASOVIEW HemoPro Endoscopic Vessel Harvesting System is a medical device that received FDA 510(k) clearance on 2016-04-19. The listed applicant is Maquet Cardiovascular, LLC. The 510(k) number is K153194.

When did VASOVIEW HemoPro Endoscopic Vessel Harvesting System receive FDA 510(k) clearance?

VASOVIEW HemoPro Endoscopic Vessel Harvesting System received FDA 510(k) clearance on 2016-04-19, under 510(k) number K153194.

Who is the listed applicant for VASOVIEW HemoPro Endoscopic Vessel Harvesting System?

The FDA 510(k) record lists Maquet Cardiovascular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VASOVIEW HemoPro Endoscopic Vessel Harvesting System?

The FDA product code for VASOVIEW HemoPro Endoscopic Vessel Harvesting System is GEI.

Essais cliniques associés

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Autres dossiers indiquant Maquet Cardiovascular, LLC en tant que demandeur

K252445Fusion Bioline Vascular Graft K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)K243918Vasoview Hemopro 3 Power Supply K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)K191930Endoscope de longueur prolongée de 7 mm K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord

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Source officielle

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