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)
Top companies in KRD
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Merit 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 |
KRD | K181300 |
| Jul 28, 2025 | MICROVENTION INC. LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400 Open, Classified |
KRD | K150958 |
| Jun 18, 2025 | BALT USA, LLC Prestige Coil System REFs/UDI-DI codes:
PRES0153CXPPLT 00810068567311
PRES1045CPKPLT 00810068567663
PRES1245CPKPLT 00810068567694
PRES1445CPKPLT 00810068567724
PRES0103CXPPLT 00810068567304
PRES2512CX Open, Classified |
KRD | K220699 |
| May 14, 2025 | Cook 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 |
KRD | None listed |
| Mar 27, 2024 | Boston Scientific Corporation Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 Open, Classified |
KRD | K213385 |
| Feb 8, 2024 | BALT 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 |
KRD | K220699 |
| Oct 27, 2023 | MICROVENTION INC. AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 Open, Classified |
KRD | K151358 |
| May 5, 2022 | Cook 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 |
KRD | K153778 |
| May 5, 2022 | Cook 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 |
KRD | K153778 |
| May 5, 2022 | Cook 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 |
KRD | K160219 |
| Nov 24, 2019 | Microvention, 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 |
KRD | K151358 |
| Nov 24, 2019 | Microvention, 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 |
KRD | K151358 |
| Nov 24, 2019 | Microvention, 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 |
KRD | K151358 |
| Nov 24, 2019 | Microvention, 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 |
KRD | K120630 |
| Nov 24, 2019 | Microvention, 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 |
KRD | K120630 |
| Nov 24, 2019 | Microvention, 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 |
KRD | K120630 |
| Dec 13, 2013 | Stryker 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 |
KRD | K993418 |
| Jan 26, 2012 | Micro 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 |
KRD | K081465 |
| Jan 10, 2006 | Cook, 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 |
KRD | None listed |
| Nov 5, 2005 | AGA 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 |
KRD | K031810 |
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