510(k) K153376 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Advanced Perfusion System 1
| Applicant | Terumo Cardiovascular Systems Corporation, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Dec 16, 2015 |
| Received | Nov 23, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153376
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2017 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1-Level Sensor II Pads,
Product Usage:
Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir. Terminated |
DTQ | None listed |
| Mar 14, 2017 | Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads
Product Usage:
Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel. Terminated |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.