40CC Percutaneous Furl Dou. Lumen Balloon Catheter
FDA 510(k) K864567 · Aries Medical, Inc.
510(k) numberK864567
Submission
- Device name
- 40CC Percutaneous Furl Dou. Lumen Balloon Catheter
- Applicant
- Aries Medical, Inc.
Woburn, MA, US - Received
- November 19, 1986
- Decision date
- May 12, 1987
- 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
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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 |
|---|---|---|
| K912604 | Sjm/Cad Isoflow(Tm) Centrifugal Pump 2100CP, ModifKFM · Traditional | 10/28/1991SE |
| K903925 | Aries Meldical Model 2100HC Hank CrankKFM · Traditional | 12/21/1990SE |
| K903442 | Aries Taperseal(Tm) SheathDYB · Traditional | 08/23/1990SE |
| K895433 | Aries 30CC & 50CC Intra-Aortic Balloon & Cont. SysDSP · Traditional | 04/10/1990SE |
| K882289 | Aries 40CC Percu. (D/L) Intra-Aortic Balloon Cath.DSY · Traditional | 12/12/1988SE |
| K864994 | 40CC Per. Pre-Furl (S/L) Intra-Aortic CatheterDSP · Traditional | 06/19/1987SE |
| K864537 | 40CC Percutaneous Pre-Furl (D/L) Balloon CatheterDSP · Traditional | 06/19/1987SE |
| K864568 | 40CC Surgical Double Lumen Balloon CatheterDSP · Traditional | 05/12/1987SE |
| K871140 | Aries Peel Away Percutaneous Catheter IntroducerDYB · Traditional | 04/22/1987SE |
| K870189 | Aries Tapered SheathDYB · Traditional | 03/16/1987SE |
Questions and answers
When was 40CC Percutaneous Furl Dou. Lumen Balloon Catheter cleared by the FDA?
40CC Percutaneous Furl Dou. Lumen Balloon Catheter (K864567) received a 510(k) decision of Substantially Equivalent on May 12, 1987, 174 days after the submission was received.
What is the product code of K864567?
The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.