CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, And Freeform XtraSoft Detachable Coil Systems

Device, Neurovascular Embolization

Medos International, SARL

The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Cerepak Uniform, Uniform Xl, Uniform 3d, Heliform Soft, Heliform Xtrasoft, Heliform Xl, Heliform Xtrasoft Xl, Freeform, Freeform Mini, And Freeform Xtrasoft Detachable Coil Systems.

Pre-market Notification Details

• Device ID: K220040
• 510k Number: K220040
• Device Name: CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, And Freeform XtraSoft Detachable Coil Systems
• Classification: Device, Neurovascular Embolization
• Applicant: Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400
• Contact: Michael Liao
• Correspondent: Michael Liao; Medos International, SARL Chemin-Blanc 38 Le Locle, CH 2400
• Product Code: HCG
• CFR Regulation Number: 882.5950 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-01-05
• Decision Date: 2022-07-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10886704083139	K220040	000
10886704083245	K220040	000
10886704083252	K220040	000
10886704083269	K220040	000
10886704083276	K220040	000
10886704083283	K220040	000
10886704083290	K220040	000
10886704083306	K220040	000
10886704083313	K220040	000
10886704083238	K220040	000
10886704083221	K220040	000
10886704083146	K220040	000
10886704083153	K220040	000
10886704083160	K220040	000
10886704083177	K220040	000
10886704083184	K220040	000
10886704083191	K220040	000
10886704083207	K220040	000
10886704083214	K220040	000
10886704083320	K220040	000
10886704083337	K220040	000
10886704083344	K220040	000
10886704083450	K220040	000
10886704083467	K220040	000
10886704083474	K220040	000
10886704083481	K220040	000
10886704083498	K220040	000
10886704083504	K220040	000
10886704083511	K220040	000
10886704083528	K220040	000
10886704083443	K220040	000
10886704083436	K220040	000
10886704083351	K220040	000
10886704083368	K220040	000
10886704083375	K220040	000
10886704083382	K220040	000
10886704083399	K220040	000
10886704083405	K220040	000
10886704083412	K220040	000
10886704083429	K220040	000
10886704083535	K220040	000
10886704083122	K220040	000
10886704083610	K220040	000
10886704083726	K220040	000
10886704083733	K220040	000
10886704083740	K220040	000
10886704083757	K220040	000
10886704083764	K220040	000
10886704083771	K220040	000
10886704083788	K220040	000
10886704082880	K220040	000
10886704083719	K220040	000
10886704083702	K220040	000
10886704083627	K220040	000
10886704083634	K220040	000
10886704083641	K220040	000
10886704083658	K220040	000
10886704083665	K220040	000
10886704083672	K220040	000
10886704083689	K220040	000
10886704083696	K220040	000
10886704082897	K220040	000
10886704082903	K220040	000
10886704082910	K220040	000
10886704083030	K220040	000
10886704083047	K220040	000
10886704083054	K220040	000
10886704083061	K220040	000
10886704083078	K220040	000
10886704083085	K220040	000
10886704083092	K220040	000
10886704083108	K220040	000
10886704083023	K220040	000
10886704083009	K220040	000
10886704082927	K220040	000
10886704082934	K220040	000
10886704082941	K220040	000
10886704082958	K220040	000
10886704082965	K220040	000
10886704082972	K220040	000
10886704082989	K220040	000
10886704082996	K220040	000
10886704083115	K220040	000
10886704084143	K220040	000
10886704084259	K220040	000
10886704084266	K220040	000
10886704084273	K220040	000
10886704084280	K220040	000
10886704084297	K220040	000
10886704084303	K220040	000
10886704084310	K220040	000
10886704084327	K220040	000
10886704084242	K220040	000
10886704084235	K220040	000
10886704084150	K220040	000
10886704084167	K220040	000
10886704084174	K220040	000
10886704084181	K220040	000
10886704084198	K220040	000
10886704084204	K220040	000
10886704084211	K220040	000
10886704084228	K220040	000
10886704084334	K220040	000
10886704084341	K220040	000
10886704084358	K220040	000
10886704084464	K220040	000
10886704084471	K220040	000
10886704084488	K220040	000
10886704084495	K220040	000
10886704084501	K220040	000
10886704084518	K220040	000
10886704084525	K220040	000
10886704084778	K220040	000
10886704084457	K220040	000
10886704084440	K220040	000
10886704084365	K220040	000
10886704084372	K220040	000
10886704084389	K220040	000
10886704084396	K220040	000
10886704084402	K220040	000
10886704084419	K220040	000
10886704084426	K220040	000
10886704084433	K220040	000
10886704083016	K220040	000
10886704084136	K220040	000
10886704083542	K220040	000
10886704083832	K220040	000
10886704083849	K220040	000
10886704083856	K220040	000
10886704083863	K220040	000
10886704083870	K220040	000
10886704083887	K220040	000
10886704083894	K220040	000
10886704083900	K220040	000
10886704083825	K220040	000
10886704083818	K220040	000
10886704083559	K220040	000
10886704083566	K220040	000
10886704083573	K220040	000
10886704083580	K220040	000
10886704083597	K220040	000
10886704083603	K220040	000
10886704083795	K220040	000
10886704083801	K220040	000
10886704083917	K220040	000
10886704083924	K220040	000
10886704083931	K220040	000
10886704084044	K220040	000
10886704084051	K220040	000
10886704084068	K220040	000
10886704084075	K220040	000
10886704084082	K220040	000
10886704084099	K220040	000
10886704084105	K220040	000
10886704084112	K220040	000
10886704084037	K220040	000
10886704084020	K220040	000
10886704083948	K220040	000
10886704083955	K220040	000
10886704083962	K220040	000
10886704083979	K220040	000
10886704083986	K220040	000
10886704083993	K220040	000
10886704084006	K220040	000
10886704084013	K220040	000
10886704084129	K220040	000