AUTOLOGOUS BLOOD COLLECTION SET— 510(k) K923016

Name: FDA 510(k) clearance K923016
Creator: U.S. Food and Drug Administration
Published: 1992-11-23

Substantially Equivalent

Advanced Haemotechnologies

FDA 510(k) clearance K923016 for AUTOLOGOUS BLOOD COLLECTION SET, Substantially Equivalent on 1992-11-23. Applicant: Advanced Haemotechnologies. Device class: 2.

Clearance details

Applicant: Advanced Haemotechnologies
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 1992-06-23
Decision date: 1992-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Woodlands, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAC

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K241236 — XTRA Collection sets; XTRA Sequestration set X2024-08-16
K240426 — Aventus Clot Management System2024-05-14
K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)2024-04-29
K231782 — FlowSaver Blood Return System (80-101)2023-07-14
K221483 — FlowSaver Blood Return System2023-02-17

Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

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 →

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