FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPIOX RX HARDSHELL RESERVOIR
K Number: K013526
·
Decision Nov 15, 2001
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
168
Applicant Total
43
Review Days
23
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Basic Information
- Device Name
- CAPIOX RX HARDSHELL RESERVOIR
- K Number
- K013526
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Cardiovascular Systems Corp.
- Date Received
- October 23, 2001
- Decision Date
- November 15, 2001
- Product Code
- DTN
- 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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Terumo Cardiovascular Systems Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 | Dec 2, 2015 | Substantially Equivalent |
| K133658 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Jul 25, 2014 | Substantially Equivalent |
| K131041 | ADVANCED PERFUSION SYSTEM 1 | Feb 20, 2014 | Substantially Equivalent |
| K132451 | SARNS SOFT-FLOW AORTIC CANNULA | Feb 18, 2014 | Substantially Equivalent |
| K133151 | SARNS HIGH FLOW AORTIC ARCH CANNULA | Feb 3, 2014 | Substantially Equivalent |
| K130333 | CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR | Mar 13, 2013 | Substantially Equivalent |
| K130359 | CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA | Mar 13, 2013 | Substantially Equivalent |
| K123039 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Nov 20, 2012 | Substantially Equivalent |
| K113214 | TLINK DATA MANAGEMENT SYSTEM (DMS) | Feb 7, 2012 | Substantially Equivalent |
| K112587 | ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, | Dec 19, 2011 | Substantially Equivalent |