FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
K Number: K131618
·
Decision Sep 27, 2013
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
20
Applicant Total
29
Review Days
116
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Basic Information
- Device Name
- LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
- K Number
- K131618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4370
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Cardiovascular Systems Corporation
- Date Received
- June 3, 2013
- Decision Date
- September 27, 2013
- Product Code
- DWB
- 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 |
|---|---|---|---|
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWB), ordered by most recent decision date.
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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Other Clearances by Terumo Cardiovascular Systems Corporation
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|---|---|---|---|
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| K221895 | Terumo Advanced Perfusion System 1 | Apr 18, 2023 | Substantially Equivalent |
| K200091 | Capiox iCP Centrifugal Pump | Nov 18, 2021 | Substantially Equivalent |
| K182110 | CDI Blood Parameter Monitoring System 550 | Nov 2, 2018 | Substantially Equivalent |
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| 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 |