DWB — Pump, Blood, Cardiopulmonary Bypass, Roller Type Class II
FDA product code DWB covers "Pump, Blood, Cardiopulmonary Bypass, Roller Type", a Class II medical device regulated under 21 CFR 870.4370. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DWB
- Device Class
- Class II
- Regulation Number
- 870.4370
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K162843 | terumo cardiovascular systems corporation | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roll | November 17, 2016 |
| K131618 | terumo cardiovascular systems corporation | LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER P | September 27, 2013 |
| K112587 | terumo cardiovascular systems | ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASS | December 19, 2011 |
| K973237 | medtronic bio-medicus | CSS-CARDIOPLEGIA SAFETY SYSTEM | April 27, 1998 |
| K972321 | stoeckert instrumente | S3 MAST PUMP | February 27, 1998 |
| K971520 | stoeckert instrumente | S3 CYCLIC RPM CONTROL | September 10, 1997 |
| K960974 | cobe cardiovascular | COBE CENTURY PERFUSION PUMP | July 14, 1997 |
| K953901 | 3m health care, sarns | SARNS 800 ROLLER PUMP | April 19, 1996 |
| K953904 | 3m health care | SARNS 9000 UNIVERSAL ROLLER PUMP | April 19, 1996 |
| K955038 | stoeckert instrumente | STOCKERT S3 DOUBLE HEAD PUMP MODULE | February 21, 1996 |
| K890904 | shiley | MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP | April 12, 1989 |
| K881780 | vascucare | VASCUCARE ANGIOPUMP | September 28, 1988 |
| K874771 | angiomed u.s | ANGIOMED INTRODUCING SETS | January 12, 1988 |
| K861714 | shiley | STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE | July 16, 1986 |
| K862116 | shiley | STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE | July 16, 1986 |
| K831458 | electromedics | CARDIOPLEGIA RECIRCULATION SYS-BL 705/A | October 20, 1983 |
| K820729 | 3m health care, sarns | SARNS PULSATILE PUMP | November 1, 1982 |
| K822071 | gambro | PUMP MODULES PMO LO-110-PMD 10-210 | August 24, 1982 |
| K813035 | advocacy international | POLYSTAN VERTICLUDE BLOOD PUMP | November 27, 1981 |
| K802714 | cobe laboratories | COBE/STOCKERT BATTERY MODULE | November 26, 1980 |