Company · Fairfield, NJ, United States
Datascope Corp.
Everything this company holds in Health Canada’s product databases, as the company’s name is spelled there.
- Drug products (DIN)
- 0
- 0 authorized now
- Natural health products
- 0
- 0 active licences
- Medical device licences
- 21
- 10 active
- Notices of Compliance
- 0
Medical device licences
Active licences first, newest first.
| Name | Licence | Status | First licensed |
|---|---|---|---|
| SENSATION PLUS | 96618 | Issued (active) · Class 4 | |
| MEGA IAB CATHETER | 91868 | Issued (active) · Class 4 | |
| CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP | 90370 | Issued (active) · Class 4 | |
| CS300 INTRA AORTIC BALLOON PUMP SYSTEM | 77561 | Issued (active) · Class 4 | |
| SENSATION 7FR. INTRA-AORTIC BALLOON CATHETER | 76664 | Issued (active) · Class 4 | |
| INSERTION KITS FOR INTRA-AORTIC BALLOON CATHETER | 69584 | Issued (active) · Class 2 | |
| LINEAR 7.5FR.INTRA-AORTIC BALLOON CATHETER WITH INSERTION KIT | 66614 | Issued (active) · Class 4 | |
| CS100I INTRA AORTIC BALLOON PUMP | 64146 | Issued (active) · Class 4 | |
| CS100 INTRA AORTIC BALLOON PUMP | 63563 | Issued (active) · Class 4 | |
| IAB CATHETER EXTENDERS | 60918 | Issued (active) · Class 2 | |
| GUIDE WIRES | 61000 | Discontinued at renewal · Class 2 | |
| INTRODUCER SET | 60919 | Discontinued at renewal · Class 2 | |
| GUIDE WIRES - STAINLESS STEEL | 60920 | Discontinued at renewal · Class 2 | |
| STEPPED VESSEL DILATORS | 60921 | Discontinued at renewal · Class 2 | |
| SYSTEM 98XT INTRA AORTIC BALLOON PUMP | 60891 | Discontinued at renewal · Class 4 | |
| 8FR. INTRA-AORTIC BALLOON CATHETERS | 60391 | Cancelled · Class 4 | |
| PERCOR STAT-DL INTRA-AORTIC BALLOON CATHETERS | 14348 | Discontinued at renewal · Class 4 | |
| PROFILE 8FR. INTRA-AORTIC BALLOON CATHETERS | 14352 | Discontinued at renewal · Class 4 | |
| 9.5 TRUE SHEATHLESS INTRA-AORTIC BALLOON CATHETERS | 14354 | Discontinued at renewal · Class 4 | |
| VASOSEAL VASCULAR HEMOSTASIS DEVICE | 944 | Cancelled: renewal not answered · Class 4 | |
| INTRA AORTIC BALLOON PUMPS | 375 | Discontinued at renewal · Class 4 |
Recalls and safety alerts that mention its products
Health Canada’s recall notices do not carry licence numbers, so these are matched by name. A notice may cover another product or only some lots: read it to see what it covers.
- Datascope Cardiosave Hybrid And Rescue Intra-Aortic Balloon Pumps (IABP)August 18, 2023 · Cardiovascular · Performance · Type II
- Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon PumpAugust 14, 2023 · Cardiovascular · Performance · Type I
- Datascope Cardiosave Hybrid And Rescue Intra-Aortic Balloon Pumps (IABP)June 16, 2023 · Cardiovascular · Performance · Type II
- Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon PumpMarch 16, 2023 · Cardiovascular · Performance · Type II
- Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon PumpFebruary 17, 2023 · Cardiovascular · Performance · Type II
- Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon PumpJanuary 4, 2023 · Cardiovascular · Performance · Type II
- Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon PumpDecember 13, 2021 · Cardiovascular · Manufacturing defect · Type II
- Cardiosave System - Battery Only (2021-09-23)October 1, 2021 · Medical devices · Medical devices · Type II
- CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP (2021-09-14)September 24, 2021 · Medical devices · Medical devices · Type II
- CS300, CS100, Cardiosave Hybrid, and Cardiosave Rescue IABP (2019-07-02)July 9, 2019 · Medical devices · Medical devices · Type I
- Cardiosave Hybrid IABP (2018-09-26)November 2, 2018 · Medical devices · Medical devices · Type II
- CARDIOSAVE Intra-Aortic Balloon Pump (IABP) (2018-05-08)May 25, 2018 · Medical devices · Medical devices · Type II
- Cardiosave Hybrid And Rescue Intra-Aortic Balloon PumpJanuary 25, 2017 · Medical devices · Type III
- CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP (2016-04-05)April 22, 2016 · Medical devices · Medical devices · Type II
- CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP (2015-12-21)January 22, 2016 · Medical devices · Health products · Type II
- Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) (2015-02-04)February 16, 2015 · Medical devices · Health products · Type III