FDA 510(k)

MODIFICATION TO ACIST CL 100H

K-Number: K991103 · 2000-05-31

Decision Date2000-05-31

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ACIST CL 100H 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 2000-05-31 under 510(k) number K991103. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ACIST CL 100H?

MODIFICATION TO ACIST CL 100H is a medical device that received FDA 510(k) clearance on 2000-05-31. The listed applicant is Acist Medical Systems. The 510(k) number is K991103.

When did MODIFICATION TO ACIST CL 100H receive FDA 510(k) clearance?

MODIFICATION TO ACIST CL 100H received FDA 510(k) clearance on 2000-05-31, under 510(k) number K991103.

Who is the listed applicant for MODIFICATION TO ACIST CL 100H?

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 MODIFICATION TO ACIST CL 100H?

The FDA product code for MODIFICATION TO ACIST CL 100H is DXT.

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Other records listing Acist Medical Systems as applicant

K020892ACIST GENTOO CONTRAST INJECTION SYSTEM K021015ACIST PLUS 4 ANGIOGRAPHIC CATHETER K000013ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 K993774ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH K984058ACIST INJECTOR SYSTEM, MODEL CL100 H

Related Devices (Code: DXT)

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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.