TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
FDA 510(k) clearance K071521 · decided 2007-11-21
Clearance details
- K-number
- K071521
- Device name
- TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
- Applicant
- Terumo Cardiovascular Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-04
- Decision date
- 2007-11-21
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- DWC
- Device class
- 2
- Regulation number
- 870.4250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Ma recall (Z-1416-2018) | Terumo Cardiovascular Systems Corporation | 2018-04-18 |
| HX2" Temperature Management Systems; The Terumo HX2" Temperature Management System provide recall (Z-2207-2016) | Terumo Cardiovascular Systems Corporation | 2016-07-14 |
| Terumo HX2 Temperature Management System provides temperature control of two independent w recall (Z-1116-2015) | Terumo Cardiovascular Systems Corporation | 2015-02-13 |
| HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, recall (Z-0278-2013) | Terumo Cardiovascular Systems Corporation | 2012-11-13 |
| Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfconta recall (Z-0279-2013) | Terumo Cardiovascular Systems Corporation | 2012-11-13 |