Transport Cart
FDA 510(k) K952576 · Belmont Instrument Corp.
510(k) numberK952576
Submission
- Device name
- Transport Cart
- Applicant
- Belmont Instrument Corp.
Billerica, MA, US - Received
- June 5, 1995
- Decision date
- December 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
| 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 |
|---|---|---|
| K152208 | The Belmont Hyperthermia PumpLGZ · Special | 09/02/2015SE |
| K141654 | The Belmont Rapid InfuserFRN · Special | 07/18/2014SE |
| K131519 | Belmont Hyperthermia PumpLGZ · Special | 11/06/2013SE |
| K112639 | The Belmont Buddy Lite Fluid WarmerBSB · Special | 11/16/2011SE |
| K091855 | The Belmont Fluid Management System/ the Belmont Rapid Infuser, Model FMS2000FRN · Special | 07/01/2009SE |
| K090508 | The Belmont Buddy Lite Fluid WarmerBSB · Special | 03/26/2009SE |
| K090089 | Belmont Hyperthermia PumpLGZ · Special | 02/12/2009SE |
| K070654 | Hyperthermia PumpLGZ · Traditional | 06/08/2007SE |
| K062774 | Belmont Buddy Plus Fluid WarmerBSB · Special | 10/19/2006SE |
| K052547 | Belmont Buddy Fluid WarmerBSB · Special | 10/13/2005SE |
Questions and answers
When was Transport Cart cleared by the FDA?
Transport Cart (K952576) received a 510(k) decision of Substantially Equivalent on December 26, 1995, 204 days after the submission was received.
What is the product code of K952576?
The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.