DeviceSignal · 510(k) cleared
Maquet Critical Care AB
FDA 510(k) decision recorded 2026-08-26 · K253715 · Traditional 510(k)
Event510(k) cleared
Effective2026-08-26
DecisionSESE
On 2026-08-26 the FDA recorded a 510(k) clearance decision for Maquet Critical Care AB, for Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…. Clearance K253715. Product code PIF. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K253715
- Applicant
- Maquet Critical Care AB
- Device
- Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)
- Decided on
- 2026-08-26
- Received on
- 2025-11-24
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- PIF
- Review days
- 275
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K253715- Snapshot hash
a17b676375c92ad46cfd0c81b2c18852150764f05c544c0889e193548d652e00- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
8071236256a749703a6ad6b9edff7e1d8582c3e9cd52233382e280c209a56acf- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)