AC3 Series IABP System
FDA 510(k) K162820 · Arrow International, Inc.
510(k) numberK162820
Submission
- Device name
- AC3 Series IABP System
- Applicant
- Arrow International, Inc.
Chelmsford, MA, US - Received
- October 7, 2016
- Decision date
- March 31, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| 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 |
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPDSP · Special | 05/27/2020SE |
| 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 |
| 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 Series IABP System cleared by the FDA?
AC3 Series IABP System (K162820) received a 510(k) decision of Substantially Equivalent on March 31, 2017, 175 days after the submission was received.
What is the product code of K162820?
The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.