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FDA 510(k)

CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM

K-Number: K062265 · 2006-12-26

ApplicantSwiss Medical Care S.A.
Decision Date2006-12-26
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Swiss Medical Care S.A.. It received FDA 510(k) clearance on 2006-12-26 under 510(k) number K062265. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM?

CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-26. The listed applicant is Swiss Medical Care S.A.. The 510(k) number is K062265.

When did CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM receive FDA 510(k) clearance?

CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM received FDA 510(k) clearance on 2006-12-26, under 510(k) number K062265.

Who is the listed applicant for CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM?

The FDA 510(k) record lists Swiss Medical Care S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM?

The FDA product code for CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM is IZQ.

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Related Devices (Code: IZQ)

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.

K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc.K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KGK251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KGK252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG

Official Source

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

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