Advanced Perfusion System 1— 510(k) K151349
Substantially EquivalentTerumo Cardiovascular Systems Corporation
FDA 510(k) clearance K151349 for Advanced Perfusion System 1, Substantially Equivalent on 2015-08-27. Applicant: Terumo Cardiovascular Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corporation
- 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 Corporation
view all- K234065 — CDI OneView Monitoring System
- K200091 — Capiox iCP Centrifugal Pump
- K182110 — CDI Blood Parameter Monitoring System 550
- K180950 — Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)
- K172071 — Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)
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.