Product Code: HCG FDA class 2 21 CFR 882.5950

Device, Neurovascular Embolization

Neurology

The Neurovascular Embolization Device is an implanted endovascular device used to deliberately occlude or reduce blood flow to intracranial vascular lesions such as arteriovenous malformations, tumors, or aneurysms, by delivering embolic material through a catheter. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and is designated as an implant. The product code is HCG under regulation 21 CFR 882.5950 in the Neurology specialty. The implant flag is active for this device.

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510(k)s

185

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HCG
Device Class: FDA class 2
Regulation Number: 882.5950
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 185 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260351	Numen Helia Coil Embolization System; NumenFR Detachment System	May 20, 2026	Substantially Equivalent	MicroPort NeuroTech (Shanghai) Co., Ltd.
K254221	Optima Coil System (OptiOne Coil System)	Jan 27, 2026	Substantially Equivalent	Balt USA, LLC
K252694	Target Detachable Coil	Dec 11, 2025	Substantially Equivalent	Stryker Neurovascular
K251832	InZone IST Detachment System; IZDS Connecting Cable	Oct 17, 2025	Substantially Equivalent	Stryker Neurovascular
K252700	Optima Coil System (Optima Packing Coil System)	Sep 26, 2025	Substantially Equivalent	Balt USA, LLC
K242154	Numen Coil Embolization System; NumenFR Detachment System	Sep 30, 2024	Substantially Equivalent	MicroPort NeuroTech (Shanghai) Co., Ltd.
K242582	Optima Coil System (OptiBlock Line Extension)	Sep 27, 2024	Substantially Equivalent	Balt USA, LLC
K242243	Target Detachable Coils	Aug 29, 2024	Substantially Equivalent	Stryker Neurovscular
K232955	Numen Coil Embolization System; NumenFR Detachment System	Jan 10, 2024	Substantially Equivalent	MicroPort NeuroTech (Shanghai) Co., Ltd.
K233420	Axium Detachable Coil; Axium Prime Detachable Coil	Nov 07, 2023	Substantially Equivalent	Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
K230284	Penumbra LP Coil System	Oct 25, 2023	Substantially Equivalent	Penumbra, Inc.
K222533	Target Tetra Detachable Coils	Dec 14, 2022	Substantially Equivalent	Stryker Neurovascular
K223386	Optima Coil System	Dec 06, 2022	Substantially Equivalent	Balt USA, LLC
K220040	CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems	Jul 14, 2022	Substantially Equivalent	Medos International SARL
K212455	InZone Detachment System	Nov 16, 2021	Substantially Equivalent	Stryker Neurovascular
K203625	Numen Coil Embolization System; NumenFR Detachment System	Sep 01, 2021	Substantially Equivalent	MicroPort NeuroTech (Shanghai) Co., Ltd.
K203432	Axium Detachable Coil; Axium Prime Detachable Coil	Jul 07, 2021	Substantially Equivalent	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
K211344	MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems	May 28, 2021	Substantially Equivalent	Medos International SARL
K210638	i-ED COIL System	Mar 26, 2021	Substantially Equivalent	Kaneka Medical America, LLC
K192068	i-ED COIL	Apr 25, 2020	Substantially Equivalent	Kaneka Pharma America, LLC
K200030	Optima Coil System	Feb 01, 2020	Substantially Equivalent	Balt USA, LLC
K192955	Penumbra LP Coil System	Nov 20, 2019	Substantially Equivalent	Penumbra, Inc.
K180653	Spartan eCoil System	Dec 04, 2018	Substantially Equivalent	Spartan Micro, Inc.
K173711	Wallaby Avenir Coil System	May 04, 2018	Substantially Equivalent	Wallaby Medical, Inc.
K173614	Penumbra Coil 400, Ruby Coil System, POD System	Apr 17, 2018	Substantially Equivalent	Penumbra, Inc.
K172390	Optima Coil System	Feb 18, 2018	Substantially Equivalent	Blockade Medical, LLC (D.B.A. Balt Usa)
K171862	GALAXY G3 Mini Microcoil Delivery System	Sep 25, 2017	Substantially Equivalent	Codman & Shurtleff, Inc.
K170852	POD Packing Coil	Jul 19, 2017	Substantially Equivalent	Penumbra, Inc.
K171747	MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System	Jul 14, 2017	Substantially Equivalent	Codman & Shurtleff, Inc.
K162999	V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System	Mar 29, 2017	Substantially Equivalent	MicroVention, Inc.
K162704	Axium Prime Detachable Coil System	Jan 03, 2017	Substantially Equivalent	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
K161452	MicroPlex Coil System (MCS) - HyperSoft 3D	Aug 31, 2016	Substantially Equivalent	MicroVention, Inc.
K161367	HydroCoil Embolic System (HES)	Aug 31, 2016	Substantially Equivalent	MicroVention, Inc.
K161429	Target Detachable Coils	Jun 22, 2016	Substantially Equivalent	Stryker Neurovascular
K153658	Target Detachable Coils	May 19, 2016	Substantially Equivalent	Stryker Neurovascular
K160832	Penumbra Smart Coil	Apr 20, 2016	Substantially Equivalent	Penumbra, Inc.
K160096	InZone Detachment System	Feb 19, 2016	Substantially Equivalent	Stryker Neurovascular
K153594	MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)	Jan 22, 2016	Substantially Equivalent	MicroVention, Inc.
K151447	Axium Detachable Coil System	Jul 28, 2015	Substantially Equivalent	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
K151760	Barricade Embolization Coil System	Jul 27, 2015	Substantially Equivalent	Blockade Medical
K151572	Penumbra Smart Coil	Jul 10, 2015	Substantially Equivalent	Penumbra, Inc.
K150319	MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS	Jun 12, 2015	Substantially Equivalent	Codman & Shurtleff, Inc.
K143218	Penumbra Smart Coil	Mar 18, 2015	Substantially Equivalent	Penumbra, Inc.
K142429	CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable	Dec 24, 2014	Substantially Equivalent	Codman & Shurtleff, Inc.
K142513	Barricade Embolization Coil System	Nov 13, 2014	Substantially Equivalent	Blockade Medical
K141134	POD SYSTEM	Jul 03, 2014	Substantially Equivalent	Penumbra, Inc.
K140104	BARRICADE EMBOLIZATION COIL SYSTEM	Feb 13, 2014	Substantially Equivalent	Blockade Medical
K133310	AXIUM DETACHABLE COIL SYSTEM	Jan 10, 2014	Substantially Equivalent	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
K132952	MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)	Dec 19, 2013	Substantially Equivalent	MicroVention, Inc.
K132482	BARRICADE EMBOLIZATION COIL SYSTEM	Oct 10, 2013	Substantially Equivalent	Blockade Medical
K131948	MICROPLEX COIL SYSTEM (MCS)	Oct 04, 2013	Substantially Equivalent	MicroVention, Inc.
K132317	MICROPLEX COIL SYSTEM (MCS), VFC	Sep 20, 2013	Substantially Equivalent	MicroVention, Inc.
K131475	BARRICADE EMBOLIZATION COIL SYSTEM	Jul 25, 2013	Substantially Equivalent	Blockade Medical
K123338	BARRICADE EMBOLIZATION COIL SYSTEM	Mar 28, 2013	Substantially Equivalent	Blockade Medical
K123560	VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM	Jan 25, 2013	Substantially Equivalent	Codman & Shurtleff, Inc.
K123377	TARGET DETACHABLE COIL	Nov 30, 2012	Substantially Equivalent	Stryker Neurovascular
K120908	HYDROCOIL EMBOLIC SYSTEM (HES)	Apr 25, 2012	Substantially Equivalent	MicroVention, Inc.
K120850	TARGET DETACHABLE COIL	Apr 17, 2012	Substantially Equivalent	Stryker Neurovascular
K120686	ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM	Apr 04, 2012	Substantially Equivalent	Codman & Shurtleff, Inc.
K120330	PENUMBRA COIL SYSTEM/PENUMBRA COIL 400	Apr 02, 2012	Substantially Equivalent	Penumbra, Inc.
K113822	QUADRASPHERE 30 TO 60	Mar 08, 2012	Substantially Equivalent	Biosphere Medical, Inc.
K120274	DELTAMAXX 18 MICROCOIL SYSTEM	Mar 02, 2012	Substantially Equivalent	Codman and Shurtleff, Inc.
K113457	HYDROCOIL EMBOLIC SYSTEM (HES)	Dec 16, 2011	Substantially Equivalent	MicroVention, Inc.
K113412	TARGET DETACHABLE COIL	Dec 13, 2011	Substantially Equivalent	Stryker Neurovascular
K112181	HYDROCOIL(R) EMBOLIC SYSTEM (HES)	Dec 01, 2011	Substantially Equivalent	MicroVention, Inc.
K112226	HYDROCOIL EMBOLIC SYSTEM (HES)	Sep 29, 2011	Substantially Equivalent	MicroVention, Inc.
K111451	MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX	Sep 20, 2011	Substantially Equivalent	MicroVention, Inc.
K112385	TRAGET DETACHABLE COIL	Sep 15, 2011	Substantially Equivalent	Stryker Neurovascular
K103758	MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10	Apr 28, 2011	Substantially Equivalent	MicroVention, Inc.
K103355	GDC 360 DETEACHABLE COIL	Feb 16, 2011	Substantially Equivalent	Boston Scientific Corp
K103305	PENUMBRA EMBOLIZATION COIL SYSTEM	Jan 26, 2011	Substantially Equivalent	Penumbra, Inc.
K103008	INZONE DETACHMENT SYSTEM	Dec 10, 2010	Substantially Equivalent	Boston Scientific Corp
K102672	TARGET DETACHABLE COIL	Oct 15, 2010	Substantially Equivalent	Boston Scientific Corp
K093973	TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM	May 26, 2010	Substantially Equivalent	Codman & Shurtleff, Inc.
K100454	HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V	Apr 22, 2010	Substantially Equivalent	MicroVention, Inc.
K094018	LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES	Apr 16, 2010	Substantially Equivalent	Biocompatibles UK Limited
K093142	TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM	Feb 04, 2010	Substantially Equivalent	Boston Scientific Corp
K093919	MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V	Jan 21, 2010	Substantially Equivalent	MicroVention, Inc.
K093358	MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V	Jan 15, 2010	Substantially Equivalent	MicroVention, Inc.
K092666	INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250	Sep 30, 2009	Substantially Equivalent	Boston Scientific Corp
K091641	HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)	Jun 30, 2009	Substantially Equivalent	MicroVention, Inc.
K090891	MICROPLEX COIL SYSTEM-COSMOS	Jun 22, 2009	Substantially Equivalent	MicroVention, Inc.
K090357	HYDROFRAME (HES)	Apr 10, 2009	Substantially Equivalent	MicroVention, Inc.
K090168	AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415	Mar 12, 2009	Substantially Equivalent	MicroVention, Inc.
K090001	V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503	Mar 05, 2009	Substantially Equivalent	MicroVention, Inc.
K083646	MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL	Jan 02, 2009	Substantially Equivalent	Micrus Endovascular Corporation
K082739	MICRUS MICROCOIL DELIVERY SYSTEM	Oct 17, 2008	Substantially Equivalent	Micrus Endovascular Corporation
K082461	BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B	Oct 02, 2008	Substantially Equivalent	MicroVention, Inc.
K082324	TRUFILL DCS SYRINGE	Sep 12, 2008	Substantially Equivalent	Cordis Neurovascular, Inc.
K080666	HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS	Jul 11, 2008	Substantially Equivalent	MicroVention, Inc.
K080379	MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT	Jun 30, 2008	Substantially Equivalent	Micrus Endovascular Corporation
K080437	MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF	May 08, 2008	Substantially Equivalent	Micrus Endovascular Corporation
K080967	TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT	May 02, 2008	Substantially Equivalent	Cordis Neurovascular, Inc.
K073442	MICRUS MICROCOIL SYSTEMS	Feb 26, 2008	Substantially Equivalent	Micrus Endovascular Corporation
K073419	PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES	Feb 14, 2008	Substantially Equivalent	Rj Medical, Inc.
K072173	MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC	Oct 05, 2007	Substantially Equivalent	Micrus Endovascular Corporation
K071962	VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)	Sep 26, 2007	Substantially Equivalent	Cordis Neurovascular, Inc.
K071634	MODIFICATION TO:CONTOUR SE MICROSPHERES	Jul 12, 2007	Substantially Equivalent	Boston Scientific Corp
K070656	HYDROCOIL EMBOLIC SYSTEM (HES)	Jun 15, 2007	Substantially Equivalent	MicroVention, Inc.
K071246	MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR	Jun 01, 2007	Substantially Equivalent	Micrus Endovascular Corporation
K060747	FX DETACHABLE COIL SYSTEM	Apr 24, 2007	Substantially Equivalent	Micro Therapeutics, Inc.
K070707	MICRUS MICROCOIL SYSTEM	Apr 06, 2007	Substantially Equivalent	Micrus Endovascular Corporation
K063653	MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC	Jan 17, 2007	Substantially Equivalent	Micrus Endovascular Corporation
K052509	M-BOLUS EMBOLIC MICROSPHERES	Dec 11, 2006	Substantially Equivalent	Scion Cardio-Vascular, Inc.
K063254	THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM	Dec 07, 2006	Substantially Equivalent	Cordis Neurovascular, Inc.
K062036	MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4	Aug 25, 2006	Substantially Equivalent	Micrus Endovascular Corporation
K060625	NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR	Apr 20, 2006	Substantially Equivalent	Micro Therapeutics, Inc.
K053548	MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES	Jan 30, 2006	Substantially Equivalent	Protein Polymer Technologies, Inc.
K053197	TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION	Dec 15, 2005	Substantially Equivalent	Cordis Neurovascular, Inc.
K053160	MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE	Dec 07, 2005	Substantially Equivalent	Micrus Endovascular Corporation
K051560	NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR	Jun 28, 2005	Substantially Equivalent	Micro Therapeutics, Inc.
K050954	MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)	Jun 28, 2005	Substantially Equivalent	MicroVention, Inc.
K051425	NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR	Jun 22, 2005	Substantially Equivalent	Micro Therapeutics, Inc.
K042297	ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES	Jun 01, 2005	Substantially Equivalent	Acta Vascular Systems, Inc.
K050543	NEXUS DETACHABLE COIL SYSTEM	Apr 27, 2005	Substantially Equivalent	Micro Therapeutics, Inc.
K050700	MATRIX STRETCH RESISTANT (SR) COILS	Apr 15, 2005	Substantially Equivalent	Boston Scientific Corp
K042231	GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES	Nov 12, 2004	Substantially Equivalent	Biocompatibles UK Limited
K042539	GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL	Oct 19, 2004	Substantially Equivalent	Boston Scientific Corp
K041649	SAPPHIRE NXT DETACHABLE COIL SYSTEM	Jul 16, 2004	Substantially Equivalent	Micro Therapeutics, Inc.
K041551	MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)	Jul 07, 2004	Substantially Equivalent	MicroVention, Inc.
K040694	MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)	Mar 25, 2004	Substantially Equivalent	Micro Therapeutics, Inc.
K032619	MICROSTAT PVA FOAM EMBOLIZATION PARTICLES	Feb 13, 2004	Substantially Equivalent	Surgica Corp.
K033813	MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE	Feb 04, 2004	Substantially Equivalent	Micrus Corp.
K033761	GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES	Feb 04, 2004	Substantially Equivalent	Biocompatibles UK Limited
K033372	SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS	Jan 09, 2004	Substantially Equivalent	Micro Therapeutics, Inc.
K033836	HYDROCOIL EMBOLIC SYSTEM (HES)	Dec 30, 2003	Substantially Equivalent	MicroVention, Inc.
K032872	MICRUS MICROCOIL SYSTEM	Nov 28, 2003	Substantially Equivalent	Micrus Corp.
K032590	MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)	Oct 22, 2003	Substantially Equivalent	MicroVention, Inc.
K032497	SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT	Sep 25, 2003	Substantially Equivalent	Micro Therapeutics, Inc.
K032707	CONTOUR SE MICROSPHERES (SYRINGE)	Sep 23, 2003	Substantially Equivalent	Boston Scientific Corp
K032553	TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM	Sep 23, 2003	Substantially Equivalent	Cordis Neurovascular, Inc.
K032542	MODIFICATION TO CONTOUR SE MICROSPHERES	Sep 16, 2003	Substantially Equivalent	Boston Scientific Corp
K031852	SAPPHIRE DETACHABLE FIBER COILS	Aug 20, 2003	Substantially Equivalent	Micro Therapeutics, Inc.
K031578	MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR	Aug 01, 2003	Substantially Equivalent	Micrus Corp.
K031049	GUGLIELMI DETACHABLE COIL (GDC)	Aug 01, 2003	Substantially Equivalent	Boston Scientific, Target
K030392	SAPPHIRE DETACHABLE COIL SYSTEM	Jul 21, 2003	Substantially Equivalent	Micro Therapeutics, Inc.
K030963	TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM	Jun 20, 2003	Substantially Equivalent	Cordis Neurovascular, Inc.
K031168	MATRIX STRETCH RESISTANT DETACHABLE COIL	May 14, 2003	Substantially Equivalent	Boston Scientific, Target
K030475	GDC STRETCH RESISTANT DETACHABLE COIL	Mar 14, 2003	Substantially Equivalent	Boston Scientific, Target
K023089	GELSPHERES EMBOLIC AGENT	Dec 16, 2002	Substantially Equivalent	Biocure, Inc.
K022420	MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01	Oct 22, 2002	Substantially Equivalent	Micrus Corp.
K022735	MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT	Sep 06, 2002	Substantially Equivalent	MicroVention, Inc.
K022427	CONTOUR SE MICROSPHERES	Aug 22, 2002	Substantially Equivalent	Boston Scientific Corp
K020434	MICROPLEX COIL SYSTEM (MCS)	Jul 29, 2002	Substantially Equivalent	MicroVention, Inc.
K021914	MICROPLEX COIL SYSTEMS (MCS)	Jul 09, 2002	Substantially Equivalent	MicroVention, Inc.
K021494	GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4	Jun 06, 2002	Substantially Equivalent	Boston Scientific, Target
K020033	MAXISTAT PVA FOAM EMBOLIZATION PARTICLES	May 31, 2002	Substantially Equivalent	Surgica Corp.
K014041	TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM	Mar 07, 2002	Substantially Equivalent	Cordis Neurovascular
K012985	MATRIX DETACHABLE COILS	Jan 31, 2002	Substantially Equivalent	Boston Scientific, Target
K012145	MICROPLEX COIL SYSTEM	Oct 29, 2001	Substantially Equivalent	MicroVention, Inc.
K010026	EMBOGOLD MICROSPHERE	Jun 21, 2001	Substantially Equivalent	Biosphere Medical, Inc.
K001678	PVA FOAM EMBOLIZATION PARTICLES	Jan 25, 2001	Substantially Equivalent	Surgica Corp.
K002056	MICRUS MICROCOIL DELIVERY SYSTEM, MDS03	Jan 11, 2001	Substantially Equivalent	Micrus Corp.
K000651	DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM	Nov 24, 2000	Substantially Equivalent	Cook, Inc.
K002181	GDC ULTRASOFT COIL	Aug 11, 2000	Substantially Equivalent	Boston Scientific, Target
K001083	GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4	May 03, 2000	Substantially Equivalent	Boston Scientific, Target
K991549	EMBOSPHERE MICROSPHERES	Apr 26, 2000	Substantially Equivalent	Biosphere Medical
K993418	FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL	Jan 21, 2000	Substantially Equivalent	Boston Scientific, Target
K993417	GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)	Jan 21, 2000	Substantially Equivalent	Boston Scientific, Target
K993415	GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1	Jan 21, 2000	Substantially Equivalent	Boston Scientific, Target
K991139	GUGLIELMI DETACHABLE (GDC)	Dec 22, 1999	Substantially Equivalent	Boston Scientific, Target
K983483	VASCULAR OCCLUSION SYSTEM	Mar 24, 1999	Substantially Equivalent	Cordis Neurovascular, Inc.
K972881	CES VASCULAR OCCLUSION SYSTEM	Jun 04, 1998	Substantially Equivalent	Cordis Neurovascular, Inc.
K964021	INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)	Mar 27, 1997	Substantially Equivalent	Baxter Edwards
K965174	TRUFILL PVA PARTICLES	Mar 21, 1997	Substantially Equivalent	Cordis Neurovascular, Inc.
K964367	CES VASCULAR OCCLUSION SYSTEM	Jan 30, 1997	Substantially Equivalent	Cordis Neurovascular, Inc.
K963307	GDC PATIENT RETURN ELECTTRODE MODEL 45021	Dec 17, 1996	Substantially Equivalent	Target Therapeutics
K962503	GUGLIELMI DETACHABLE COIL	Sep 20, 1996	Substantially Equivalent	Target Therapeutics
K961923	BERENSTEIN COIL	Aug 15, 1996	Substantially Equivalent	Target Therapeutics
K960705	GUGLIELMI DETACHABLE COIL	May 21, 1996	Substantially Equivalent	Target Therapeutics
K951256	DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)	Sep 08, 1995	Substantially Equivalent	Target Therapeutics
K951314	TRUEFILL PVA PARTICLES	Aug 08, 1995	Substantially Equivalent	Cordis Neurovascular, Inc.
K944354	CONTOUR EMBOLI	Dec 13, 1994	Substantially Equivalent	Interventional Therapeutics Corp.
K913556	IVALON EMBOLIZATION PARTICLES	Apr 13, 1994	Substantially Equivalent	Ivalon
K914866	ITC CONTOUR EMBOLI, MODIFICATION	Nov 09, 1993	Substantially Equivalent	Interventional Therapeutics Corp.
K925876	ITC BUNJI PLATINUM EMBOLIZATION COIL	Apr 15, 1993	Substantially Equivalent	Interventional Therapeutics Corp.
K925523	ITC BUNJI PLATINUM EMBOLIZATION COIL	Mar 23, 1993	Substantially Equivalent	Interventional Therapeutics Corp.
K920324	ITC BUNJI COIL (MODIFICATION)	Jul 29, 1992	Unknown	Interventional Therapeutics Corp.
K913312	HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED	Nov 08, 1991	Substantially Equivalent	Target Therapeutics
K911779	HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED	Nov 08, 1991	Substantially Equivalent	Target Therapeutics
K900723	ITC BUNJI COIL	Feb 19, 1991	Substantially Equivalent	Interventional Therapeutics Corp.
K901337	HILAL EMBOLIZATION MICROCOIL(TM)	Nov 13, 1990	Substantially Equivalent	Cook, Inc.
K901721	MODIFIED TARGET THERAPEUTICS COILS	Jul 03, 1990	Substantially Equivalent	Target Therapeutics
K891688	COIL AND COIL DELIVERY SYSTEM	Sep 22, 1989	Substantially Equivalent	Target Therapeutics
K871047	RADIOPAQUE SPHERICAL EMBOLI (RSE)	May 22, 1987	Substantially Equivalent	Interventional Therapeutics Corp.