510(k) K960974
- Device
- COBE CENTURY PERFUSION PUMP
- Applicant
- COBE CARDIOVASCULAR, INC.
- 510(k) number
- K960974
- Product code
- DWB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-07-14
- Date received
- 1996-03-11
- Regulation
- 870.4370
- Classification name
- Pump, Blood, Cardiopulmonary Bypass, Roller Type
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY L ARMSTRONG
- Address
- 14401 W. 65th Way Arvada CO US 80004 80004
FDA Registration Numbers#
- 3001589655
- 3042990265
- 1828100
Source Documents#
Other 510(k) Records For Product Code DWB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K112587 | ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, | Terumo Cardiovascular Systems Corp. | 2011-12-19 |
| K973237 | CSS-CARDIOPLEGIA SAFETY SYSTEM | Medtronic Bio-Medicus, Inc. | 1998-04-27 |
| K972321 | S3 MAST PUMP | Stoeckert Instrumente | 1998-02-27 |
| K971520 | S3 CYCLIC RPM CONTROL | Stoeckert Instrumente | 1997-09-10 |
| K953901 | SARNS 800 ROLLER PUMP | 3M Health Care, Sarns | 1996-04-19 |
| K953904 | SARNS 9000 UNIVERSAL ROLLER PUMP | 3M Health Care, Ltd. | 1996-04-19 |
| K955038 | STOCKERT S3 DOUBLE HEAD PUMP MODULE | Stoeckert Instrumente | 1996-02-21 |
| K890904 | MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP | Shiley, Inc. | 1989-04-12 |
| K881780 | VASCUCARE ANGIOPUMP | Vascucare, Inc. | 1988-09-28 |
| K874771 | ANGIOMED INTRODUCING SETS | Angiomed U.S., Inc. | 1988-01-12 |
| K861714 | STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE | Shiley, Inc. | 1986-07-16 |
| K862116 | STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE | Shiley, Inc. | 1986-07-16 |
| K831458 | CARDIOPLEGIA RECIRCULATION SYS-BL 705/A | Electromedics, Inc. | 1983-10-20 |
Legacy Summary#
summary
FDA Review#
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