FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Capiox iCP Centrifugal Pump
K Number: K200091
·
Decision Nov 18, 2021
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
83
Applicant Total
29
Review Days
672
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Basic Information
- Device Name
- Capiox iCP Centrifugal Pump
- K Number
- K200091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Terumo Cardiovascular Systems Corporation
- Date Received
- January 16, 2020
- Decision Date
- November 18, 2021
- Product Code
- KFM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | FDA class 2 | Cardiovascular |
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Other Clearances by Terumo Cardiovascular Systems Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K234065 | CDI OneView Monitoring System | Apr 25, 2024 | Substantially Equivalent |
| K221895 | Terumo Advanced Perfusion System 1 | Apr 18, 2023 | Substantially Equivalent |
| K182110 | CDI Blood Parameter Monitoring System 550 | Nov 2, 2018 | Substantially Equivalent |
| 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) | Jun 22, 2018 | Substantially Equivalent |
| 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) | Mar 29, 2018 | Substantially Equivalent |
| K172220 | Advanced Perfusion System 1 | Aug 17, 2017 | Substantially Equivalent |
| K163531 | Advanced Perfusion System 1 | Jun 7, 2017 | Substantially Equivalent |
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 | Nov 17, 2016 | Substantially Equivalent |
| K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting System | Apr 21, 2016 | Substantially Equivalent |
| K153376 | Advanced Perfusion System 1 | Dec 16, 2015 | Substantially Equivalent |