FDA.reportPublic FDA data

510(k) K254221

Device
Optima Coil System (OptiOne Coil System)
Applicant
Balt USA, LLC
510(k) number
K254221
Product code
HCG
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-27
Date received
2025-12-29
Regulation
882.5950
Classification name
Device, Neurovascular Embolization
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Kavita Chandrashekar
Address
29 Parker Irvine CA US 92618 92618

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HCG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261772Target Xtra Detachable CoilStryker Neurovscular2026-06-24
K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2026-05-20
K252694Target Detachable CoilStryker Neurovascular2025-12-11
K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular2025-10-17
K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC2025-09-26
K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2024-09-30
K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC2024-09-27
K242243Target Detachable CoilsStryker Neurovscular2024-08-29
K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2024-01-10
K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular2023-11-07
K230284Penumbra LP Coil SystemPenumbra, Inc.2023-10-25
K222533Target Tetra Detachable CoilsStryker Neurovascular2022-12-14
K223386Optima Coil SystemBalt USA, LLC2022-12-06
K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil SystemsMedos International SARL2022-07-14
K212455InZone Detachment SystemStryker Neurovascular2021-11-16