FDA.report

510(k) K242582

Device
Optima Coil System (OptiBlock Line Extension)
Applicant
Balt USA, LLC
510(k) number
K242582
Product code
HCG
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-27
Date received
2024-08-30
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
No

Related Records

Applicant Contact

Contact
Kavita Chandrashekar
Address
29 Parker Irvine CA US 92618 92618

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00840303711933Optima Coil SystemBALT USA LLC2024-10-07
00840303712404Optima Coil SystemBALT USA LLC2024-10-07
00840303712398Optima Coil SystemBALT USA LLC2024-10-07
00840303712381Optima Coil SystemBALT USA LLC2024-10-07
00840303712374Optima Coil SystemBALT USA LLC2024-10-07
00840303711995Optima Coil SystemBALT USA LLC2024-10-07
00840303711988Optima Coil SystemBALT USA LLC2024-10-07
00840303711971Optima Coil SystemBALT USA LLC2024-10-07
00840303711964Optima Coil SystemBALT USA LLC2024-10-07
00840303711957Optima Coil SystemBALT USA LLC2024-10-07
00840303711940Optima Coil SystemBALT USA LLC2024-10-07
00840303712411Optima Coil SystemBALT USA LLC2024-10-07
00840303711926Optima Coil SystemBALT USA LLC2024-10-07
00840303711919Optima Coil SystemBALT USA LLC2024-10-07
00840303711902Optima Coil SystemBALT USA LLC2024-10-07
00840303711896Optima Coil SystemBALT USA LLC2024-10-07
00840303711889Optima Coil SystemBALT USA LLC2024-10-07
00840303711872Optima Coil SystemBALT USA LLC2024-10-07
00840303711865Optima Coil SystemBALT USA LLC2024-10-07
00840303711858Optima Coil SystemBALT USA LLC2024-10-07
00810068568981Optima Coil SystemBALT USA LLC2024-10-07
00810068568707Optima Coil SystemBALT USA LLC2024-10-07
00840303712527Optima Coil SystemBALT USA LLC2024-10-07
00840303712657Optima Coil SystemBALT USA LLC2024-10-07
00840303712640Optima Coil SystemBALT USA LLC2024-10-07
00840303712633Optima Coil SystemBALT USA LLC2024-10-07
00840303712626Optima Coil SystemBALT USA LLC2024-10-07
00840303712619Optima Coil SystemBALT USA LLC2024-10-07
00840303712602Optima Coil SystemBALT USA LLC2024-10-07
00840303712596Optima Coil SystemBALT USA LLC2024-10-07

Other 510(k) Records For Product Code HCG

510(k)DeviceApplicantDecision date
K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2026-05-20
K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC2026-01-27
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
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
K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.2021-09-01