ClearanceBrief
Panels › Cardiovascular › Product code KRD · Class 2

Device, Vascular, For Promoting Embolization

Regulation 870.3300

8510(k)s in 12 months (133 all time)
1recalls in 12 months (20 all time)
18recalls that name a 510(k)
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Top companies in KRD

DateFirm and productCodeLinked 510(k)
Sep 25, 2026Merit Medical Systems, Inc.
Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere 900-1200 micrometer 2 mL
Open, Classified
KRDK181300
Jul 28, 2025MICROVENTION INC.
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Open, Classified
KRDK150958
Jun 18, 2025BALT USA, LLC
Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CX
Open, Classified
KRDK220699
May 14, 2025Cook Incorporated
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-
Open, Classified
KRDNone listed
Mar 27, 2024Boston Scientific Corporation
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Open, Classified
KRDK213385
Feb 8, 2024BALT USA, LLC
The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral va
Open, Classified
KRDK220699
Oct 27, 2023MICROVENTION INC.
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Open, Classified
KRDK151358
May 5, 2022Cook Incorporated
Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417
Open, Classified
KRDK153778
May 5, 2022Cook Incorporated
Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NES
Open, Classified
KRDK153778
May 5, 2022Cook Incorporated
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Open, Classified
KRDK160219
Nov 24, 2019Microvention, Inc.
Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, M
Terminated
KRDK151358
Nov 24, 2019Microvention, Inc.
Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo
Terminated
KRDK151358
Nov 24, 2019Microvention, Inc.
Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030
Terminated
KRDK151358
Nov 24, 2019Microvention, Inc.
Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-7
Terminated
KRDK120630
Nov 24, 2019Microvention, Inc.
Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA;
Terminated
KRDK120630
Nov 24, 2019Microvention, Inc.
Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202,
Terminated
KRDK120630
Dec 13, 2013Stryker Neurovascular
Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/
Terminated
KRDK993418
Jan 26, 2012Micro Therapeutics Inc, dba ev3 Neurovascular
Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such a
Terminated
KRDK081465
Jan 10, 2006Cook, Inc.
Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038'' end hole; Reorder # MWCE-38-20-20.
Terminated
KRDNone listed
Nov 5, 2005AGA Medical Corporation
AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages
Terminated
KRDK031810

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