FDA Product Code
FDA Product Code DWC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4250
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220635 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | 2022-11-16 | Traditional | PDF ↗ |
| K212657 | Quantum Heater-Cooler | Spectrum Medical , Ltd. | 2022-05-06 | Traditional | PDF ↗ |
| K191402 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | 2020-02-25 | Traditional | PDF ↗ |
| K140012 | SORIN FLEXTHERM | Sorin Group Deutschland GmbH | 2014-01-31 | Special | PDF ↗ |
| K130300 | HEATER-COOLER UNIT HCU 40 | Maquet Cardiopulmonary, AG | 2013-07-01 | Traditional | PDF ↗ |
| K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM | Cincinnati Sub-Zero Products, Inc. | 2012-12-18 | Traditional | PDF ↗ |
| K102147 | CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 | Cardioquip Llp | 2010-11-19 | Traditional | PDF ↗ |
| K071521 | TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM | Terumo Cardiovascular Systems Corp. | 2007-11-21 | Traditional | PDF ↗ |
| K052601 | STOCKERT HEATER-COOLER SYSTEM 3T | Sorin Group Deutschland GmbH | 2006-06-06 | Traditional | PDF ↗ |
| K031544 | HEATER COOLER UNIT, MODEL HCU 30 | Jostra AB | 2003-08-07 | Traditional | PDF ↗ |
| K014016 | ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER | Minntech Corp. | 2002-02-01 | Traditional | PDF ↗ |
| K003145 | ORIGEN BLADDER HOLDER | Origen Biomedical, Inc. | 2001-04-20 | Traditional | PDF ↗ |
| K001520 | ALPHA OMEGA DUAL COOLER-HEATER | Alpha Omega, Inc. | 2000-11-22 | Traditional | PDF ↗ |
| K945720 | JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE | Jostra Bentley | 1995-03-29 | Traditional | PDF ↗ |
| K896973 | CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320 | Daily Medical Products, Inc. | 1990-02-05 | Traditional | PDF ↗ |
| K896972 | CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 | Daily Medical Products, Inc. | 1990-02-05 | Traditional | PDF ↗ |
| K896975 | CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220 | Daily Medical Products, Inc. | 1990-02-05 | Traditional | PDF ↗ |
| K896974 | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 | Daily Medical Products, Inc. | 1990-02-05 | Traditional | PDF ↗ |
| K896971 | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 | Daily Medical Products, Inc. | 1990-02-05 | Traditional | PDF ↗ |
| K896393 | CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 | Daily Medical, Inc. | 1990-02-02 | Traditional | PDF ↗ |
| K893940 | POLYSTAN HEATER-COOLER UNIT | Polystan C/O Vitalcor, Inc. | 1990-01-18 | Traditional | PDF ↗ |
| K883603 | SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) | 3M Health Care, Sarns | 1988-11-03 | Traditional | PDF ↗ |
| K873924 | PTI HEART-CHILL POUCH/PAD SLING (STERILE) | Buckman Co., Inc. | 1988-02-02 | Traditional | PDF ↗ |
| K874927 | PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET | Pioneering Technologies, Inc. | 1988-01-29 | Traditional | PDF ↗ |
| K873699 | ECMO-TEMP (TM) BLOOD WARMING DEVICE | Seabrook Medical Systems, Inc. | 1987-12-22 | Traditional | PDF ↗ |
| K873813 | SARNS WARMER, PART #164975 AND #164980 | 3M Health Care, Sarns | 1987-11-06 | Traditional | PDF ↗ |
| K841402 | TEMPERATURE CONTROL & MONITOR | Sams, Inc. | 1984-06-11 | Traditional | PDF ↗ |
| K831677 | HYPER-HYPOTHERMIA UNIT HYPO 10-200 | Gambro, Inc. | 1983-07-18 | Traditional | PDF ↗ |
| K822874 | THERMOSTATIC WATER MIXING VALVE TWV10 | Gambro, Inc. | 1982-10-18 | Traditional | PDF ↗ |
| K810647 | SHILEY OXYGENATOR THERMISTOR PROBE | Shiley, Inc. | 1981-04-03 | Traditional | PDF ↗ |
Product code DWC · Class II · Cardiovascular. Data: openFDA.