Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329
FDA 510(k) K994157 · Datascope Corp.
510(k) numberK994157
Submission
- Device name
- Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329
- Applicant
- Datascope Corp.
Fairfield, NJ, US - Received
- December 9, 1999
- Decision date
- March 13, 2000
- 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
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 |
|---|---|---|
| K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolGDW · Traditional | 12/26/2019SE |
| K181122 | CARDIOSAVE Intra-Aortic Balloon PumpDSP · Special | 05/31/2018SE |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDSP · Special | 10/12/2017SE |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…DSP · Special | 01/31/2017SE |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDSP · Special | 07/02/2015SE |
| K133074 | Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDSP · Special | 12/12/2013SE |
| K071805 | Netguard Automated Clinician Alert System, Model 0998-00-1600-XXDSI · Abbreviated | 09/25/2007SE |
| K062569 | Safeguard 24 CM Pressure Assisted DressingDXC · Abbreviated | 02/14/2007SE |
| K062098 | Spectrum Monitor, Model 0998-00-1000-XXXXXMHX · Abbreviated | 02/05/2007SE |
| K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…DSP · Special | 01/05/2007SE |
Questions and answers
When was Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329 cleared by the FDA?
Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329 (K994157) received a 510(k) decision of Substantially Equivalent on March 13, 2000, 95 days after the submission was received.
What is the product code of K994157?
The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.