510(k) K172220 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Advanced Perfusion System 1
| Applicant | Terumo Cardiovascular Systems Corporation, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Aug 17, 2017 |
| Received | Jul 24, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172220
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2021 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Electronic Patient Gas System
Catalog #: 801188 Terminated |
DTQ | None listed |
| Aug 25, 2020 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gros Terminated |
DTQ | None listed |
| Aug 25, 2020 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to det Terminated |
DTQ | None listed |
| Aug 25, 2020 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gros Terminated |
DTQ | None listed |
| Jan 10, 2020 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, Terminated |
DTQ | None listed |
| Jan 10, 2020 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, Terminated |
DTQ | None listed |
| Jan 10, 2020 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion Assembly Pump Guts, 6 Inch, Catalog Number 801798 - is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusi Terminated |
DTQ | None listed |
| Jan 10, 2020 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, r Terminated |
DTQ | None listed |
| Apr 18, 2019 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588
The electronic gas blender provides control and monitoring of the gas flow rate and oxygen conte Terminated |
DTQ | None listed |
| Oct 17, 2018 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass. Terminated |
DTQ | None listed |
| Sep 13, 2018 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Electronic Patient
Gas System, Catalog#: 801188 Terminated |
DTQ | None listed |
| Aug 28, 2018 | Terumo Cardiovascular Systems Corporation Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures.
Catalog Number 801763 Terminated |
DTQ | None listed |
| Aug 28, 2018 | Terumo Cardiovascular Systems Corporation Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures.
Catalog Number 801764 Terminated |
DTQ | None listed |
| Jan 19, 2018 | Terumo Cardiovascular Systems Corporation Flowmeter Module (accessory to Terumo Advanced
Perfusion System 1).
Provides the interface between the flow sensor and the system. Terminated |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.