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FDA 510(k)

ACIST INJECTOR SYSTEM, MODEL CL100 H

K-Number: K984058 · 1999-02-11

ApplicantAcist Medical Systems
Decision Date1999-02-11
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACIST INJECTOR SYSTEM, MODEL CL100 H is the device name listed in this FDA 510(k) record. The listed applicant is Acist Medical Systems. It received FDA 510(k) clearance on 1999-02-11 under 510(k) number K984058. 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 ACIST INJECTOR SYSTEM, MODEL CL100 H?

ACIST INJECTOR SYSTEM, MODEL CL100 H is a medical device that received FDA 510(k) clearance on 1999-02-11. The listed applicant is Acist Medical Systems. The 510(k) number is K984058.

When did ACIST INJECTOR SYSTEM, MODEL CL100 H receive FDA 510(k) clearance?

ACIST INJECTOR SYSTEM, MODEL CL100 H received FDA 510(k) clearance on 1999-02-11, under 510(k) number K984058.

Who is the listed applicant for ACIST INJECTOR SYSTEM, MODEL CL100 H?

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

What is the FDA product code for ACIST INJECTOR SYSTEM, MODEL CL100 H?

The FDA product code for ACIST INJECTOR SYSTEM, MODEL CL100 H is IZQ.

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Other records listing Acist Medical Systems 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.

K020892ACIST GENTOO CONTRAST INJECTION SYSTEMK021015ACIST PLUS 4 ANGIOGRAPHIC CATHETERK991103MODIFICATION TO ACIST CL 100HK000013ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000K993774ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH

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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