Bard 9FR., 40CC. Rediguard and Taperseal Intra-Aortic Balloons
FDA 510(k) K980850 · C.R. Bard, Inc.
510(k) numberK980850
Submission
- Device name
- Bard 9FR., 40CC. Rediguard and Taperseal Intra-Aortic Balloons
- Applicant
- C.R. Bard, Inc.
Haverhill, MA, US - Received
- March 5, 1998
- Decision date
- June 3, 1998
- 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
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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 |
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| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
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| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
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Questions and answers
When was Bard 9FR., 40CC. Rediguard and Taperseal Intra-Aortic Balloons cleared by the FDA?
Bard 9FR., 40CC. Rediguard and Taperseal Intra-Aortic Balloons (K980850) received a 510(k) decision of Substantially Equivalent on June 3, 1998, 90 days after the submission was received.
What is the product code of K980850?
The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.