FDA Product Code
FDA Product Code DWB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4370
510(k) Clearances — 21 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 2016-11-17 | Special | PDF ↗ |
| K131618 | LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST | Terumo Cardiovascular Systems Corporation | 2013-09-27 | Traditional | PDF ↗ |
| K112587 | ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, | Terumo Cardiovascular Systems Corp. | 2011-12-19 | Traditional | PDF ↗ |
| K973237 | CSS-CARDIOPLEGIA SAFETY SYSTEM | Medtronic Bio-Medicus, Inc. | 1998-04-27 | Traditional | PDF ↗ |
| K972321 | S3 MAST PUMP | Stoeckert Instrumente | 1998-02-27 | Traditional | PDF ↗ |
| K971520 | S3 CYCLIC RPM CONTROL | Stoeckert Instrumente | 1997-09-10 | Traditional | PDF ↗ |
| K960974 | COBE CENTURY PERFUSION PUMP | Cobe Cardiovascular, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K953904 | SARNS 9000 UNIVERSAL ROLLER PUMP | 3M Health Care, Ltd. | 1996-04-19 | Traditional | PDF ↗ |
| K953901 | SARNS 800 ROLLER PUMP | 3M Health Care, Sarns | 1996-04-19 | Traditional | PDF ↗ |
| K955038 | STOCKERT S3 DOUBLE HEAD PUMP MODULE | Stoeckert Instrumente | 1996-02-21 | Traditional | PDF ↗ |
| K890904 | MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP | Shiley, Inc. | 1989-04-12 | Traditional | PDF ↗ |
| K881780 | VASCUCARE ANGIOPUMP | Vascucare, Inc. | 1988-09-28 | Traditional | PDF ↗ |
| K874771 | ANGIOMED INTRODUCING SETS | Angiomed U.S., Inc. | 1988-01-12 | Traditional | PDF ↗ |
| K861714 | STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE | Shiley, Inc. | 1986-07-16 | Traditional | PDF ↗ |
| K862116 | STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE | Shiley, Inc. | 1986-07-16 | Traditional | PDF ↗ |
| K831458 | CARDIOPLEGIA RECIRCULATION SYS-BL 705/A | Electromedics, Inc. | 1983-10-20 | Traditional | PDF ↗ |
| K820729 | SARNS PULSATILE PUMP | 3M Health Care, Sarns | 1982-11-01 | Traditional | PDF ↗ |
| K822071 | PUMP MODULES PMO LO-110-PMD 10-210 | Gambro, Inc. | 1982-08-24 | Traditional | PDF ↗ |
| K813035 | POLYSTAN VERTICLUDE BLOOD PUMP | Advocacy International, Ltd. | 1981-11-27 | Traditional | PDF ↗ |
| K802714 | COBE/STOCKERT BATTERY MODULE | Cobe Laboratories, Inc. | 1980-11-26 | Traditional | PDF ↗ |
| K780942 | BLOOD PUMP MODEL 7000 | 3M Health Care, Sarns | 1978-06-19 | Traditional | PDF ↗ |
Product code DWB · Class II · Cardiovascular. Data: openFDA.