FDA.reportPublic FDA data

510(k) K221934

Device
CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
Applicant
Cerenovus, Inc.
510(k) number
K221934
Product code
NRY
Decision
Substantially Equivalent
Decision date
2023-03-09
Date received
2022-07-01
Regulation
870.1250
Classification name
Catheter, Thrombus Retriever
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Clearance type
Traditional
Third party reviewed
No

Other 510(k) Records For Product Code NRY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd.2026-08-28
K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.2026-08-13
K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC2026-08-12
K262399Millipede SystemPerfuze, Ltd.2026-08-12
K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.2026-07-16
K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.2026-06-10
K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited2026-05-20
K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.2026-05-07
K253590Millipede SystemPerfuze, Ltd.2026-03-16
K253062Tigertriever 25 Revascularization DeviceRapid Medical Ltd.2026-03-12
K251357Esperance pHLO Aspiration SystemPhenox, Ltd.2026-01-15
K251006NeVasc Aspiration SystemVesalio, Inc.2025-11-10
K252046Zoom System (Zoom 4S Catheter)Imperative Care, Inc.2025-10-30
K251603Tigertriever 17 Ultra Revascularization DeviceRapid Medical Ltd.2025-10-06
K251789EMBOTRAP III Revascularization DeviceNeuravi Limited2025-09-25