ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX

Introducer, Catheter

ST. JUDE MEDICAL, INC.

The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Ultimum Hemostasis Introducer, Model 4076xx.

Pre-market Notification Details

• Device ID: K001346
• 510k Number: K001346
• Device Name: ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
• Classification: Introducer, Catheter
• Applicant: ST. JUDE MEDICAL, INC. 14901 DEVEAU PLACE Minnetonka, MN 55345
• Contact: Paul Cornelison
• Correspondent: Paul Cornelison; ST. JUDE MEDICAL, INC. 14901 DEVEAU PLACE Minnetonka, MN 55345
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-04-28
• Decision Date: 2000-05-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05414734015936	K001346	000
15414734011072	K001346	000
15414734011096	K001346	000
15414734011119	K001346	000
15414734013021	K001346	000
15414734015933	K001346	000
15414734015957	K001346	000
15414734015971	K001346	000
15414734015995	K001346	000
15414734011058	K001346	000
15414734009000	K001346	000
15414734008980	K001346	000
15414734008805	K001346	000
15414734008829	K001346	000
15414734008843	K001346	000
15414734008867	K001346	000
15414734008881	K001346	000
15414734008928	K001346	000
15414734008942	K001346	000
15414734008966	K001346	000
15414734016015	K001346	000
15414734016039	K001346	000
15414734025598	K001346	000
15414734025659	K001346	000
15414734025680	K001346	000
15414734025697	K001346	000
15414734054710	K001346	000
15414734054734	K001346	000
15414734054758	K001346	000
15414734054772	K001346	000
15414734025567	K001346	000
15414734016237	K001346	000
15414734016213	K001346	000
15414734016053	K001346	000
15414734016077	K001346	000
15414734016091	K001346	000
15414734016114	K001346	000
15414734016138	K001346	000
15414734016152	K001346	000
15414734016176	K001346	000
15414734016190	K001346	000
15415067000740	K001346	000