ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B— 510(k) K984231

Name: FDA 510(k) clearance K984231
Creator: U.S. Food and Drug Administration
Published: 2000-05-31

Substantially Equivalent

Invasatec

FDA 510(k) clearance K984231 for ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B, Substantially Equivalent on 2000-05-31. Applicant: Invasatec. Device class: 2.

Clearance details

Applicant: Invasatec
Product code: Code DXT
Device class: Class 2
Regulation: 21 CFR 870.1650
Advisory panel: Cardiovascular
Date received: 1998-11-25
Decision date: 2000-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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K963982 — ACIST ANGIOGRAPHIC INJECTOR1997-12-05

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K984231

K-number listed on FDA's recall record

Z-0744-2016 — ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). To be used for the controlled infusion of radiopaque contrast media for angiographic proceduresClass II·Terminated·Acist Medical Systems·20151221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K984231.

Data sourced from openFDA. This site is unofficial and independent of the FDA.