M-Bolus Embolic Microspheres

FDA 510(k) K052509 · Scion Cardio-Vascular, Inc.

Substantially Equivalent

510(k) numberK052509

Submission

Device name
M-Bolus Embolic Microspheres
Applicant
Scion Cardio-Vascular, Inc.
Miami, FL, US
Received
September 13, 2005
Decision date
December 11, 2006
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HCG – Device, Neurovascular Embolization
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5950
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code HCG

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K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…HCG · Special Cerenovus, Inc.08/14/2026SE
K261772Target Xtra Detachable CoilHCG · Special Stryker Neurovscular06/24/2026SE
K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemHCG · Special MicroPort NeuroTech (Shanghai) Co., Ltd.05/20/2026SE
K254221Optima Coil System (OptiOne Coil System)HCG · Special Balt USA, LLC01/27/2026SE
K252694Target Detachable CoilHCG · Traditional Stryker Neurovascular12/11/2025SE
K251832InZone IST Detachment System; IZDS Connecting CableHCG · Special Stryker Neurovascular10/17/2025SE
K252700Optima Coil System (Optima Packing Coil System)HCG · Special Balt USA, LLC09/26/2025SE
K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemHCG · Special MicroPort NeuroTech (Shanghai) Co., Ltd.09/30/2024SE
K242582Optima Coil System (OptiBlock Line Extension)HCG · Special Balt USA, LLC09/27/2024SE
K242243Target Detachable CoilsHCG · Special Stryker Neurovscular08/29/2024SE

More from Stryker Neurovscular

510(k)DeviceDecision
K112961Clo-Surplus P.A.D.QSY · Special 10/31/2011SE
K092552Clo-Surplus P.A.D.QSY · Traditional 09/04/2009SE
K032986Clo-Surplusp.A.D.QSY · Traditional 03/01/2004SE

Questions and answers

When was M-Bolus Embolic Microspheres cleared by the FDA?

M-Bolus Embolic Microspheres (K052509) received a 510(k) decision of Substantially Equivalent on December 11, 2006, 454 days after the submission was received.

What is the product code of K052509?

The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.