CDI BLOOD PARAMETER MONITORING SYSTEM 500— 510(k) K123039
Substantially EquivalentTerumo Cardiovascular Systems Corp.
FDA 510(k) clearance K123039 for CDI BLOOD PARAMETER MONITORING SYSTEM 500, Substantially Equivalent on 2012-11-20. Applicant: Terumo Cardiovascular Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corp.
- Product code
- Code DRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.4330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Recent devices under product code DRY
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
- K131041 — ADVANCED PERFUSION SYSTEM 1
- K132451 — SARNS SOFT-FLOW AORTIC CANNULA
- K133151 — SARNS HIGH FLOW AORTIC ARCH CANNULA
Adverse events under product code DRY
product code DRY- Death
- 5
- Total
- 5
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.