Barricade Embolization Coil System

FDA 510(k) K151760 · Blockade Medical

Substantially Equivalent

510(k) numberK151760

Submission

Device name
Barricade Embolization Coil System
Applicant
Blockade Medical
Irvine, CA, US
Received
June 29, 2015
Decision date
July 27, 2015
Decision
Substantially Equivalent (SESE)
Type
Special 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

510(k)DeviceApplicantDecision
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
K142513Barricade Embolization Coil SystemHCG · Special 11/13/2014SE
K140104Barricade Embolization Coil SystemHCG · Special 02/13/2014SE
K132482Barricade Embolization Coil SystemHCG · Special 10/10/2013SE
K131475Barricade Embolization Coil SystemHCG · Special 07/25/2013SE
K123338Barricade Embolization Coil SystemHCG · Traditional 03/28/2013SE

Questions and answers

When was Barricade Embolization Coil System cleared by the FDA?

Barricade Embolization Coil System (K151760) received a 510(k) decision of Substantially Equivalent on July 27, 2015, 28 days after the submission was received.

What is the product code of K151760?

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