Fukuda Denshi Cardimax FK-11
FDA 510(k) K813023 · Brentwood Instruments, Inc.
510(k) numberK813023
Submission
- Device name
- Fukuda Denshi Cardimax FK-11
- Applicant
- Brentwood Instruments, Inc.
Mchenry, IL, US - Received
- October 27, 1981
- Decision date
- December 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K162820 | AC3 Series IABP SystemDSP · Traditional | Arrow International, Inc. | 03/31/2017SE |
More from Arrow International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896924 | Spiroscan 4000BZG · Traditional | 03/01/1990SE |
| K882366 | Rhythmscan HR Holter RecorderDSH · Traditional | 08/02/1988SE |
| K871572 | RhythmscanDSI · Traditional | 02/22/1988SE |
| K860024 | Fukuda Denshi Cardimax FCP-211DSI · Traditional | 03/31/1986SE |
| K853979 | Cardimax FX-1164DPS · Traditional | 02/06/1986SE |
| K854505 | Cardimax FX-406UDRS · Traditional | 02/04/1986SE |
| K851135 | Spiro ScanBZG · Traditional | 07/01/1985SE |
| K851124 | T-1000 ECG TransmitterDXH · Traditional | 05/15/1985SE |
| K851123 | R-1000 ECG ReceiverDXH · Traditional | 05/15/1985SE |
| K842976 | Brentwood Ez Scan 200 Ambulatory ECGDSI · Traditional | 03/01/1985SE |
Questions and answers
When was Fukuda Denshi Cardimax FK-11 cleared by the FDA?
Fukuda Denshi Cardimax FK-11 (K813023) received a 510(k) decision of Substantially Equivalent on December 2, 1981, 36 days after the submission was received.
What is the product code of K813023?
The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.