Intra-Aortic Balloon Pump Model K2000
FDA 510(k) K853062 · Kontron Instruments, Inc.
510(k) numberK853062
Submission
- Device name
- Intra-Aortic Balloon Pump Model K2000
- Applicant
- Kontron Instruments, Inc.
Everett, MA, US - Received
- July 19, 1985
- Decision date
- January 22, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSP – System, Balloon, Intra-Aortic And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3535
- Specialty
- Cardiovascular
Other 510(k)s with product code DSP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250542 | AC3 Range Intra-Aortic Balloon PumpDSP · Special | Arrow International, LLC | 03/26/2025SE |
| K232343 | AC3 Series IABPDSP · Special | Arrow International, LLC | 08/30/2023SE |
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPDSP · Special | Arrow International, Inc. | 05/27/2020SE |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter KitDSP · Special | Arrow International, Inc. | 04/09/2020SE |
| K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP)DSP · Special | Arrow International, Teleflex | 11/12/2019SE |
| K190101 | UltraFlex IABDSP · Traditional | Arrow International, Inc. | 06/28/2019SE |
| K190117 | Fiberoptix IABDSP · Traditional | Arrow International, Inc. | 06/13/2019SE |
| K181122 | CARDIOSAVE Intra-Aortic Balloon PumpDSP · Special | Datascope Corp. | 05/31/2018SE |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDSP · Special | Datascope Corp. | 10/12/2017SE |
| K162820 | AC3 Series IABP SystemDSP · Traditional | Arrow International, Inc. | 03/31/2017SE |
More from Arrow International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971038 | Kontron Kolormon Plus ECG with Respiration ModuleDPS · Traditional | 09/24/1997SE |
| K932268 | Modifications to Intra-Aortic BalloonsDSP · Traditional | 12/15/1993SE |
| K925248 | Modification of Intra-Aortic Balloon CathetersDSP · Traditional | 09/27/1993SE |
| K923603 | Intra-Aortic Balloon Pump Catheter - ModificationDYB · Traditional | 03/08/1993SE |
| K905313 | Kontron Intra-Aortic Balloon Pump, Model Kaat IIDSP · Traditional | 06/19/1991SE |
| K903344 | 9.5 FR Percutaneous DB Lumen 40CC Flexi-Cath (TM)DSP · Traditional | 01/15/1991SE |
| K896437 | Kontron Sigma 44 HVCD Ultrasound Imaging SystemDPT · Traditional | 12/03/1990SE |
| K892222 | 9.5F Percu Double Lumen Intra-Aortic BalloonDSP · Traditional | 09/14/1990SE |
| K882955 | Supermon Neonatal Non-Invasive Blood Press. 7283DXN · Traditional | 01/26/1990SE |
| K896386 | Minimon 7133B Patient MonitorDPS · Traditional | 12/13/1989SE |
Questions and answers
When was Intra-Aortic Balloon Pump Model K2000 cleared by the FDA?
Intra-Aortic Balloon Pump Model K2000 (K853062) received a 510(k) decision of Substantially Equivalent on January 22, 1986, 187 days after the submission was received.
What is the product code of K853062?
The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.