HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
FDA 510(k) clearance K122813 · decided 2012-12-18
Clearance details
- K-number
- K122813
- Device name
- HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
- Applicant
- Cincinnati Sub-Zero Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-09-13
- Decision date
- 2012-12-18
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- DWC
- Device class
- 2
- Regulation number
- 870.4250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sharonville, OH, US
- Third-party review
- No
- Expedited review
- No
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| CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 (K102147) | Cardioquip Llp | 2010-11-19 |
| TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM (K071521) | Terumo Cardiovascular Systems Corp. | 2007-11-21 |
| STOCKERT HEATER-COOLER SYSTEM 3T (K052601) | Sorin Group Deutschland GmbH | 2006-06-06 |
| HEATER COOLER UNIT, MODEL HCU 30 (K031544) | Jostra AB | 2003-08-07 |
| ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER (K014016) | Minntech Corp. | 2002-02-01 |
| ORIGEN BLADDER HOLDER (K003145) | Origen Biomedical, Inc. | 2001-04-20 |
| ALPHA OMEGA DUAL COOLER-HEATER (K001520) | Alpha Omega, Inc. | 2000-11-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir Cooler/Heater recall (Z-0063-2019) | Cincinnati Sub-Zero Products LLC, a Gentherm Company | 2018-10-03 |
| Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual recall (Z-0629-2018) | Cincinnati Sub-Zero Products LLC | 2018-02-13 |
| The Hemotherm 400CE 115v, containing power board p/n 39945 recall (Z-0654-2017) | Cincinnati Sub-Zero Products Inc | 2016-11-22 |