Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02
FDA 510(k) K091449 · Datascope Corp., Cardiac Assist Division
510(k) numberK091449
Submission
- Device name
- Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02
- Applicant
- Datascope Corp., Cardiac Assist Division
Fairfield, NJ, US - Received
- May 18, 2009
- Decision date
- June 18, 2009
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K122405 | Air-Band Radial Compression DeviceDXC · Traditional | 11/09/2012SE |
| K122628 | Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDSP · Special | 09/06/2012SE |
| K120868 | Mega(Tm) 7.5FR. 30CC Intra-Aortic Balloon Catheter and Accessories, Mega(Tm) 7.5FR. 40CC…DSP · Special | 04/20/2012SE |
Questions and answers
When was Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02 cleared by the FDA?
Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02 (K091449) received a 510(k) decision of Substantially Equivalent on June 18, 2009, 31 days after the submission was received.
What is the product code of K091449?
The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.