FDA 510(k)

MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY

K-Number: K063090 · 2007-03-27

Decision Date2007-03-27

Product CodeIZQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 2007-03-27 under 510(k) number K063090. 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 MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY?

MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY is a medical device that received FDA 510(k) clearance on 2007-03-27. The listed applicant is Medrad, Inc.. The 510(k) number is K063090.

When did MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY receive FDA 510(k) clearance?

MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY received FDA 510(k) clearance on 2007-03-27, under 510(k) number K063090.

Who is the listed applicant for MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY?

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

What is the FDA product code for MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY?

The FDA product code for MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY is IZQ.

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Other records listing Medrad, Inc. as applicant

K130381ANGIOJET ULTRA POWER PULSE KIT K130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM K122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM K113363ANGIOJET SOLENT DISTA THROMBECTOMY SET K113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE K113428ANGIOJET ULTRA DVX THROMBECTOMY SET

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Related Devices (Code: IZQ)

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. KG K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG K252689MEDRAD 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.