510(k) K071521
- Device
- TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
- Applicant
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- 510(k) number
- K071521
- Product code
- DWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-11-21
- Date received
- 2007-06-04
- Regulation
- 870.4250
- Classification name
- Controller, Temperature, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK A BUR
- Address
- 6200 Jackson Rd. Ann Arbor MI US 48103 48103
FDA Registration Numbers#
- 1723241
- 1928237
- 1516825
- 9611109
- 3006073153
- 3001588119
- 3007899424
- 1828100
- 1720929
- 1649914
Source Documents#
Other 510(k) Records For Product Code DWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220635 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | 2022-11-16 |
| K212657 | Quantum Heater-Cooler | Spectrum Medical , Ltd. | 2022-05-06 |
| K191402 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | 2020-02-25 |
| K140012 | SORIN FLEXTHERM | Sorin Group Deutschland GmbH | 2014-01-31 |
| K130300 | HEATER-COOLER UNIT HCU 40 | Maquet Cardiopulmonary, AG | 2013-07-01 |
| K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM | Cincinnati Sub-Zero Products, Inc. | 2012-12-18 |
| K102147 | CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 | Cardioquip Llp | 2010-11-19 |
| K052601 | STOCKERT HEATER-COOLER SYSTEM 3T | Sorin Group Deutschland GmbH | 2006-06-06 |
| K031544 | HEATER COOLER UNIT, MODEL HCU 30 | Jostra AB | 2003-08-07 |
| K014016 | ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER | Minntech Corp. | 2002-02-01 |
| K003145 | ORIGEN BLADDER HOLDER | Origen Biomedical, Inc. | 2001-04-20 |
| K001520 | ALPHA OMEGA DUAL COOLER-HEATER | Alpha Omega, Inc. | 2000-11-22 |
| K945720 | JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE | Jostra Bentley | 1995-03-29 |
| K896971 | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 | Daily Medical Products, Inc. | 1990-02-05 |
| K896972 | CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 | Daily Medical Products, Inc. | 1990-02-05 |
Legacy Summary#
summary
FDA Review#
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