FDA 510(k)

ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B

K-Number: K984231 · 2000-05-31

Decision Date2000-05-31

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B is the device name listed in this FDA 510(k) record. The listed applicant is Invasatec. It received FDA 510(k) clearance on 2000-05-31 under 510(k) number K984231. 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 ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B?

ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B is a medical device that received FDA 510(k) clearance on 2000-05-31. The listed applicant is Invasatec. The 510(k) number is K984231.

When did ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B receive FDA 510(k) clearance?

ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B received FDA 510(k) clearance on 2000-05-31, under 510(k) number K984231.

Who is the listed applicant for ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B?

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 ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B?

The FDA product code for ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B 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

K963982ACIST ANGIOGRAPHIC INJECTOR

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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.