Angiomed Introducing Sets
FDA 510(k) K874771 · Angiomed U.S., Inc.
510(k) numberK874771
Submission
- Device name
- Angiomed Introducing Sets
- Applicant
- Angiomed U.S., Inc.
Anaheim, CA, US - Received
- November 19, 1987
- Decision date
- January 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4370
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…DWB · Special | Terumo Cardiovascular Systems Corporation | 11/17/2016SE |
| K131618 | Large (6) Roller Pump for Terumo Advanced Perfusion System 1; Large (6) Roller Pump for…DWB · Traditional | Terumo Cardiovascular Systems Corporation | 09/27/2013SE |
| K112587 | Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,DWB · Traditional | Terumo Cardiovascular Systems Corp. | 12/19/2011SE |
| K973237 | Css-Cardioplegia Safety SystemDWB · Traditional | Medtronic Bio-Medicus, Inc. | 04/27/1998SE |
| K972321 | S3 Mast PumpDWB · Traditional | Stoeckert Instrumente | 02/27/1998SE |
| K971520 | S3 Cyclic RPM ControlDWB · Traditional | Stoeckert Instrumente | 09/10/1997SE |
| K960974 | Cobe Century Perfusion PumpDWB · Traditional | Cobe Cardiovascular, Inc. | 07/14/1997SE |
| K953904 | Sarns 9000 Universal Roller PumpDWB · Traditional | 3M Health Care, Ltd. | 04/19/1996SE |
| K953901 | Sarns 800 Roller PumpDWB · Traditional | 3M Health Care, Sarns | 04/19/1996SE |
| K955038 | Stockert S3 Double Head Pump ModuleDWB · Traditional | Stoeckert Instrumente | 02/21/1996SE |
More from Stoeckert Instrumente
| 510(k) | Device | Decision |
|---|---|---|
| K874585 | Angiomed Osty-Cut Bone Biopsy NeedleDWO · Traditional | 12/02/1987SE |
| K864225 | Angiomed Ureteral D&M Sets/Ureteroscopy Guid StentFAD · Traditional | 01/30/1987SE |
| K863386 | Vesico Suprapubic Bladder Drainage & Exchange SetsKOB · Traditional | 10/24/1986SE |
| K862805 | Angiomed Vac-U-Cut Biopsy NeedleGDM · Traditional | 09/29/1986SE |
| K863446 | Angiomed High Pressure ConnectorsGCD · Traditional | 09/23/1986SE |
| K854910 | AngioflowDQO · Traditional | 07/17/1986SE |
| K854912 | Angiomed Guied WiresDQX · Traditional | 04/16/1986SE |
| K854908 | UroflexFAD · Traditional | 03/14/1986SE |
| K855143 | Angiomed Exchange Drainage Catheter SetsKOD · Traditional | 03/11/1986SE |
| K855142 | Angiomed Percutaneous Transhepatic CholangiogtaphyFGE · Traditional | 03/11/1986SE |
Questions and answers
When was Angiomed Introducing Sets cleared by the FDA?
Angiomed Introducing Sets (K874771) received a 510(k) decision of Substantially Equivalent on January 12, 1988, 54 days after the submission was received.
What is the product code of K874771?
The FDA product code is DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4370.