ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM— 510(k) K992723

Name: FDA 510(k) clearance K992723
Creator: U.S. Food and Drug Administration
Published: 1999-10-18

Substantially Equivalent

Transfusion Technologies Corp.

FDA 510(k) clearance K992723 for ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM, Substantially Equivalent on 1999-10-18. Applicant: Transfusion Technologies Corp.. Device class: 2.

Clearance details

Applicant: Transfusion Technologies Corp.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 1999-08-13
Decision date: 1999-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, 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

More clearances from Transfusion Technologies Corp.

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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 →

Recalls naming K992723

K-number listed on FDA's recall record

Z-2950-2018 — Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical proceduresClass II·Terminated·Haemonetics Corporation·20180713

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992723.

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