FDA.reportPublic FDA data

510(k) K242608

Device
Embozene Color-Advanced Microspheres
Applicant
Varian Medical Systems, Inc.
510(k) number
K242608
Product code
KRD
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-17
Date received
2024-09-03
Regulation
870.3300
Classification name
Device, Vascular, For Promoting Embolization
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lynn Allman
Address
3100 Hansen Way Palo Alto CA US 94304 94304

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KRD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.2026-04-10
K253511Concerto Versa™ Detachable CoilMedtronic, Inc.2026-01-14
K253677Tembo Embolic SystemInstylla, Inc.2025-12-15
K253376OBSIDIO™ Conformable Embolic (M0013972101010)Boston Scientific Corporation2025-10-30
K250209Polyvinyl Alcohol Embolic MicrospheresCanyon Medical, Inc.2025-09-23
K250133HARBOR Occlusion DeviceNuvascular, Inc.2025-07-09
K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC2025-05-30
K250971Embosphere MicrospheresBiosphere Medical, S.A.2025-05-16
K250276Nitinol Enhanced Device (NED)Embolization, Inc.2025-05-15
K250079Ruby XL SystemPenumbra, Inc.2025-03-14
K240873TEMBO Embolic SystemInstylla, Inc.2024-12-16
K242794ONCOZENE MicrospheresVarian Medical Systems, Inc.2024-10-16
K242507OBSIDIO™ Conformable EmbolicBoston Scientific2024-10-03
K232934SunsphereHangzhou Yangshun Medical Technology Co.,Ltd2024-05-30
K240261Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)Merit Medical Systems, Inc.2024-05-02