DSP · System, Balloon, Intra-Aortic And Control
Cardiovascular · 21 CFR 870.3535 · Class 2
Overview
| Product Code | DSP |
|---|---|
| Device Name | System, Balloon, Intra-Aortic And Control |
| Regulation | 21 CFR 870.3535 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.
Classification Rationale
(1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. (2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation.
Special Controls
*Classification.* (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device; (ii) Software verification, validation, and hazard analysis must be performed; (iii) The device must be demonstrated to be biocompatible; (iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; (v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and (vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device. (2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation. (c) *Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required.* A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
Recent Cleared Devices (20 of 162)
Showing 20 most recent of 162 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250542 | AC3 Range Intra-Aortic Balloon Pump | Arrow International, LLC | Mar 26, 2025 | SESE |
| K232343 | AC3 Series IABP | Arrow International, LLC | Aug 30, 2023 | SESE |
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | Arrow International, Inc. | May 27, 2020 | SESE |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit | Arrow International, Inc. | Apr 9, 2020 | SESE |
| K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP) | Arrow International, Teleflex | Nov 12, 2019 | SESE |
| K190101 | UltraFlex IAB | Arrow International, Inc. | Jun 28, 2019 | SESE |
| K190117 | Fiberoptix IAB | Arrow International, Inc. | Jun 13, 2019 | SESE |
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | Datascope Corp. | May 31, 2018 | SESE |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | Datascope Corp. | Oct 12, 2017 | SESE |
| K162820 | AC3 Series IABP System | Arrow International, Inc. | Mar 31, 2017 | SESE |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case | Datascope Corp. | Jan 31, 2017 | SESE |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | Datascope Corp. | Jul 2, 2015 | SESE |
| K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES | Datascope Corp. | Dec 12, 2013 | SESE |
| K122628 | SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES | Datascope Corp., Cardiac Assist Division | Sep 6, 2012 | SESE |
| K120868 | MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER | Datascope Corp., Cardiac Assist Division | Apr 20, 2012 | SESE |
| K112372 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP | Cardiac Assist, Maquet Cardiovascular, LLC | Sep 15, 2011 | SESE |
| K112327 | SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES | Cardiac Assist, Maquet Cardiovascular, LLC | Sep 9, 2011 | SESE |
| K091449 | DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 | Datascope Corp., Cardiac Assist Division | Jun 18, 2009 | SESE |
| K082746 | ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 | Insightra Medical, Inc. | Jan 12, 2009 | SESE |
| K070225 | SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE | Abiomed, Inc. | Dec 13, 2007 | SESE |
Top Applicants
- Datascope Corp. — 64 clearances
- Kontron Instruments, Inc. — 17 clearances
- Arrow Intl., Inc. — 15 clearances
- Boston Scientific Corp — 14 clearances
- Aries Medical, Inc. — 8 clearances
