ADVANCED PERFUSION SYSTEM 1— 510(k) K131041
Substantially EquivalentTerumo Cardiovascular Systems Corp.
FDA 510(k) clearance K131041 for ADVANCED PERFUSION SYSTEM 1, Substantially Equivalent on 2014-02-20. Applicant: Terumo Cardiovascular Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corp.
- Product code
- Code DTQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Recent devices under product code DTQ
view allMore clearances from Terumo Cardiovascular Systems Corp.
view all- 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 Xcoating
- K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500
- K132451 — SARNS SOFT-FLOW AORTIC CANNULA
- K133151 — SARNS HIGH FLOW AORTIC ARCH CANNULA
- K130333 — CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
Adverse events under product code DTQ
product code DTQ- Death
- 123
- Malfunction
- 4,822
- Other
- 1
- Total
- 4,946
Source: openFDA MAUDE database, through . 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.