AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
FDA 510(k) K201112 · Arrow International, Inc.
510(k) numberK201112
Submission
- Device name
- AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
- Applicant
- Arrow International, Inc.
Chelmsford, MA, US - Received
- April 27, 2020
- Decision date
- May 27, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…DSP · Special | Datascope Corp. | 01/31/2017SE |
More from Datascope Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K250542 | AC3 Range Intra-Aortic Balloon PumpDSP · Special | 03/26/2025SE |
| K232343 | AC3 Series IABPDSP · Special | 08/30/2023SE |
| K222341 | Arrow 0.2 Micron Flat Filter, GVSCAZ · Traditional | 02/13/2023SE |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter KitDSP · Special | 04/09/2020SE |
| K190101 | UltraFlex IABDSP · Traditional | 06/28/2019SE |
| K190117 | Fiberoptix IABDSP · Traditional | 06/13/2019SE |
| K162820 | AC3 Series IABP SystemDSP · Traditional | 03/31/2017SE |
| K141051 | Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis…MSD · Special | 07/07/2014SE |
| K130192 | Nextstep RetrogradeMSD · Traditional | 05/10/2013SESK |
| K130876 | Cg+ Arrow Picc Powered by Arrow VPS StyletLJS · Special | 04/26/2013SE |
Questions and answers
When was AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP cleared by the FDA?
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP (K201112) received a 510(k) decision of Substantially Equivalent on May 27, 2020, 30 days after the submission was received.
What is the product code of K201112?
The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.