FDA 510(k)

ACIST ANGIOGRAPHIC INJECTOR

K-Number: K963982 · 1997-12-05

Decision Date1997-12-05

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ACIST ANGIOGRAPHIC INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Invasatec. It received FDA 510(k) clearance on 1997-12-05 under 510(k) number K963982. 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 ACIST ANGIOGRAPHIC INJECTOR?

ACIST ANGIOGRAPHIC INJECTOR is a medical device that received FDA 510(k) clearance on 1997-12-05. The listed applicant is Invasatec. The 510(k) number is K963982.

When did ACIST ANGIOGRAPHIC INJECTOR receive FDA 510(k) clearance?

ACIST ANGIOGRAPHIC INJECTOR received FDA 510(k) clearance on 1997-12-05, under 510(k) number K963982.

Who is the listed applicant for ACIST ANGIOGRAPHIC INJECTOR?

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

What is the FDA product code for ACIST ANGIOGRAPHIC INJECTOR?

The FDA product code for ACIST ANGIOGRAPHIC INJECTOR is DXT.

Related Clinical Trials

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.

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Other records listing Invasatec as applicant

K984231ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B

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.