DSP — System, Balloon, Intra-Aortic And Control Class II
FDA product code DSP covers "System, Balloon, Intra-Aortic And Control", a Class II medical device regulated under 21 CFR 870.3535. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DSP
- Device Class
- Class II
- Regulation Number
- 870.3535
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250542 | arrow international | AC3 Range Intra-Aortic Balloon Pump | March 26, 2025 |
| K232343 | arrow international | AC3 Series IABP | August 30, 2023 |
| K201112 | arrow international | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | May 27, 2020 |
| K200634 | arrow international | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit | April 9, 2020 |
| K192238 | arrow international, teleflex | AC3 Series Intra-Aortic Balloon Pump (IABP) | November 12, 2019 |
| K190101 | arrow international | UltraFlex IAB | June 28, 2019 |
| K190117 | arrow international | Fiberoptix IAB | June 13, 2019 |
| K181122 | datascope | CARDIOSAVE Intra-Aortic Balloon Pump | May 31, 2018 |
| K172305 | datascope | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | October 12, 2017 |
| K162820 | arrow international | AC3 Series IABP System | March 31, 2017 |
| K163542 | datascope | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Batter | January 31, 2017 |
| K151254 | datascope | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | July 2, 2015 |
| K133074 | datascope | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND A | December 12, 2013 |
| K122628 | datascope corp., cardiac assist division | SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES | September 6, 2012 |
| K120868 | datascope corp., cardiac assist division | MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5 | April 20, 2012 |
| K112372 | cardiac assist, maquet cardiovascular | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP | September 15, 2011 |
| K112327 | cardiac assist, maquet cardiovascular | SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES | September 9, 2011 |
| K091449 | datascope corp., cardiac assist division | DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684 | June 18, 2009 |
| K082746 | insightra medical | ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 | January 12, 2009 |
| K070225 | abiomed | SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE | December 13, 2007 |