LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1— 510(k) K131618
Substantially EquivalentTerumo Cardiovascular Systems Corporation
FDA 510(k) clearance K131618 for LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1, Substantially Equivalent on 2013-09-27. Applicant: Terumo Cardiovascular Systems Corporation. Device class: 2.
Clearance details
- Device name as filed
- LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
- Applicant
- Terumo Cardiovascular Systems Corporation
- Product code
- Code DWB
- Device class
- Class 2
- Regulation
- 21 CFR 870.4370
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Recent devices under product code DWB
view all- K162843 — Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
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- K973237 — CSS-CARDIOPLEGIA SAFETY SYSTEM
- K972321 — S3 MAST PUMP
- K971520 — S3 CYCLIC RPM CONTROL
More clearances from Terumo Cardiovascular Systems Corporation
view all- K234065 — CDI OneView Monitoring System
- K221895 — Terumo Advanced Perfusion System 1
- 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)
Adverse events under product code DWB
product code DWB- Death
- 2
- Total
- 2
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.