DESTINO TWIST, STEERABLE GUIDING SHEATH

Introducer, Catheter

Oscor Inc.

The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Destino Twist, Steerable Guiding Sheath.

Pre-market Notification Details

• Device ID: K140406
• 510k Number: K140406
• Device Name: DESTINO TWIST, STEERABLE GUIDING SHEATH
• Classification: Introducer, Catheter
• Applicant: Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683
• Contact: Tina Strickland
• Correspondent: Tina Strickland; Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-02-18
• Decision Date: 2014-04-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885672004095	K140406	000
00885672011185	K140406	000
00885672011178	K140406	000
00885672011161	K140406	000
00885672011154	K140406	000
00885672011147	K140406	000
00885672011130	K140406	000
00885672011123	K140406	000
00885672011116	K140406	000
00885672011109	K140406	000
00885672011093	K140406	000
00885672011086	K140406	000
00885672011079	K140406	000
00885672011192	K140406	000
00885672010904	K140406	000
00885672004071	K140406	000
00885672004064	K140406	000
00885672004057	K140406	000
00885672004040	K140406	000
00885672004033	K140406	000
00885672004026	K140406	000
00885672004019	K140406	000
00885672004002	K140406	000
00885672009496	K140406	000
00885672009878	K140406	000
00885672009861	K140406	000
00885672010911	K140406	000
00885672011062	K140406	000
00885672011055	K140406	000
00885672011048	K140406	000
00885672012601	K140406	000
00885672012595	K140406	000
00885672012588	K140406	000
00885672012571	K140406	000
00885672012564	K140406	000
00885672012557	K140406	000
00885672012540	K140406	000
00885672012533	K140406	000
00885672012526	K140406	000
00885672012519	K140406	000
00885672012502	K140406	000
00885672012496	K140406	000
00885672012618	K140406	000
00885672012625	K140406	000
00885672011031	K140406	000
00885672011024	K140406	000
00885672011017	K140406	000
00885672011000	K140406	000
00885672010997	K140406	000
00885672010980	K140406	000
00885672010973	K140406	000
00885672010966	K140406	000
00885672010959	K140406	000
00885672010942	K140406	000
00885672011246	K140406	000
00885672011239	K140406	000
00885672012489	K140406	000
00885672008819	K140406	000
00885672006860	K140406	000
00885672006853	K140406	000
00885672006846	K140406	000
00885672006839	K140406	000
00885672006822	K140406	000
00885672006716	K140406	000
00885672006570	K140406	000
00885672006563	K140406	000
00885672006556	K140406	000
00885672006549	K140406	000
00885672006532	K140406	000
00885672006525	K140406	000
00885672006877	K140406	000
00885672006884	K140406	000
00885672008598	K140406	000
00885672007836	K140406	000
00885672007683	K140406	000
00885672007676	K140406	000
00885672007423	K140406	000
00885672007218	K140406	000
00885672007096	K140406	000
00885672007089	K140406	000
00885672007072	K140406	000
00885672007065	K140406	000
00885672007010	K140406	000
00885672006952	K140406	000
00885672006518	K140406	000
00885672006501	K140406	000
00885672006471	K140406	000
00885672004224	K140406	000
00885672004217	K140406	000
00885672004200	K140406	000
00885672004194	K140406	000
00885672004187	K140406	000
00885672004170	K140406	000
00885672004163	K140406	000
00885672004156	K140406	000
00885672004149	K140406	000
00885672004132	K140406	000
00885672004125	K140406	000
00885672004118	K140406	000
00885672004248	K140406	000
00885672004255	K140406	000
00885672006402	K140406	000
00885672006181	K140406	000
00885672005696	K140406	000
00885672005689	K140406	000
00885672005627	K140406	000
00885672005597	K140406	000
00885672004422	K140406	000
00885672004415	K140406	000
00885672004408	K140406	000
00885672004286	K140406	000
00885672004279	K140406	000
00885672004262	K140406	000
00885672004101	K140406	000