CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA— 510(k) K130359

Clearance details

Applicant

Terumo Cardiovascular Systems Corp.

Product code

Code DTZ

Device class

Class 2

Regulation

21 CFR 870.4350

Advisory panel

Cardiovascular

Date received

2013-02-13

Decision date

2013-03-13

Decision

Substantially Equivalent

Clearance type

Special

Location

Elkton, MD, US

• K253838 — Lifemotion Disposable Membrane Oxygenator2026-03-16
• K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) +2 more2026-03-12
• K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300) +2 more2025-12-12
• K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)2025-11-24
• K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E22024-09-12

• K153140 — Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating2015-12-02
• K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 5002014-07-25
• K131041 — ADVANCED PERFUSION SYSTEM 12014-02-20
• K132451 — SARNS SOFT-FLOW AORTIC CANNULA2014-02-18
• K133151 — SARNS HIGH FLOW AORTIC ARCH CANNULA2014-02-03

Death

182

Injury

422

Malfunction

3,636

Total

4,240

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 →