S3 Mast Pump
FDA 510(k) K972321 · Stoeckert Instrumente
510(k) numberK972321
Submission
- Device name
- S3 Mast Pump
- Applicant
- Stoeckert Instrumente
North Attleboro, MA, US - Received
- June 23, 1997
- Decision date
- February 27, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K890904 | Modified Stockert-Shiley Caps Multi. Roller PumpDWB · Traditional | Shiley, Inc. | 04/12/1989SE |
More from Shiley, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002273 | Stockert A272 Series Pediatric Aortic CannulaeDWF · Abbreviated | 01/29/2001SE |
| K001961 | Stockert A242 and A252 Series Arterial Femoral CannulaeDWF · Abbreviated | 01/25/2001SE |
| K002118 | Stockert Compact System Version 2.0DTQ · Special | 08/09/2000SE |
| K992635 | Interface Module IdddKRI · Special | 12/20/1999SE |
| K990512 | Stockert Power Supply Unit for S3 ComponentsKRI · Traditional | 11/23/1999SE |
| K982014 | Stockert Compact SystemDTQ · Special | 09/04/1998SE |
| K971520 | S3 Cyclic RPM ControlDWB · Traditional | 09/10/1997SE |
| K962320 | S3 Cardioplegia ControlDTR · Traditional | 01/10/1997SE |
| K955152 | Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. Ctrl., Temp Mont., TimerDTW · Traditional | 02/22/1996SE |
| K955038 | Stockert S3 Double Head Pump ModuleDWB · Traditional | 02/21/1996SE |
Questions and answers
When was S3 Mast Pump cleared by the FDA?
S3 Mast Pump (K972321) received a 510(k) decision of Substantially Equivalent on February 27, 1998, 249 days after the submission was received.
What is the product code of K972321?
The FDA product code is DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4370.