510(k)
K172071: Terumo Capiox NX19 Oxygenator with Reservoir (east orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation), Terumo Capiox NX19 Oxygenator (east orientation), Terumo Capiox NX19 Oxygenator (west orientation)
FDA 510(k) · Terumo Cardiovascular Systems Corporation · decided Mar 29, 2018
Key facts
| 510(k) number | K172071 |
|---|---|
| Device name | Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation) |
| Applicant | Terumo Cardiovascular Systems Corporation |
| Product code | DTZ |
| Subsequent product codes | DTN |
| Date received | Jul 10, 2017 |
| Decision date | Mar 29, 2018 |
| Decision | Substantially equivalent (SESE) |
| Submission type | Traditional |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
At a glance
- None MAUDE adverse event reports
- None Recall events
- None UDI device identifiers (GUDID)
- 1–9 Predicate devices cited
- 1–9 Later submissions citing this device
- 100–999 510(k)s with this product code
- Yes 510(k) summary on file
- No 510(k) statement on file
- Not listed On the FDA AI-enabled device list
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
Reading a 510(k)
- Decision
- SESE means the FDA found the device substantially equivalent to its predicate, so it may be marketed in the United States.
- Predicates
- Each clearance cites one or more legally marketed devices; the chain of predicates shows where a technology came from.
- Product code
- The three-letter code sets the device type, class and regulation, and groups competing clearances.
- Summary or statement
- Applicants file either a 510(k) summary of the safety and effectiveness information or a statement that it is available on request.
About 510(k) premarket notifications
A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Source: U.S. Food and Drug Administration (FDA), 510(k) Premarket Notification database · Source date: