SORIN FLEXTHERM
FDA 510(k) clearance K140012 · decided 2014-01-31
Clearance details
- K-number
- K140012
- Device name
- SORIN FLEXTHERM
- Applicant
- Sorin Group Deutschland GmbH
- Decision
- Substantially Equivalent
- Date received
- 2014-01-02
- Decision date
- 2014-01-31
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DWC
- Device class
- 2
- Regulation number
- 870.4250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Arvada, CO, US
- Third-party review
- No
- Expedited review
- No
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| Quantum Heater-Cooler (K212657) | Spectrum Medical , Ltd. | 2022-05-06 |
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| HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (K122813) | Cincinnati Sub-Zero Products, Inc. | 2012-12-18 |
| 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
No recalls on record reference this clearance.