JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

JOSTRA AG

The following data is part of a premarket notification filed by Jostra Ag with the FDA for Jostra Single Stage Venous Return Catheters.

Pre-market Notification Details

• Device ID: K020784
• 510k Number: K020784
• Device Name: JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: JOSTRA AG P.O. BOX 218 Oxford, PA 19363
• Contact: Kathleen Johnson
• Correspondent: Kathleen Johnson; JOSTRA AG P.O. BOX 218 Oxford, PA 19363
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-03-11
• Decision Date: 2003-01-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04037691395371	K020784	000
04037691006291	K020784	000
04037691059792	K020784	000
04037691432908	K020784	000
04037691396880	K020784	000
04037691184524	K020784	000
04037691416946	K020784	000
04037691095158	K020784	000
04037691146089	K020784	000
04037691025292	K020784	000
04037691008042	K020784	000
04037691004846	K020784	000
04037691004853	K020784	000
04037691004815	K020784	000
04037691004808	K020784	000
04037691396866	K020784	000
04037691175874	K020784	000
04037691396903	K020784	000
04037691422947	K020784	000
04037691011493	K020784	000
04037691012933	K020784	000
04037691019529	K020784	000
04037691019499	K020784	000
04037691184203	K020784	000
04037691409665	K020784	000
04037691051468	K020784	000
04037691092324	K020784	000
04037691092355	K020784	000
04037691121765	K020784	000
04037691287249	K020784	000
04037691142913	K020784	000
04037691182384	K020784	000
04037691142920	K020784	000
04037691095943	K020784	000
04037691212869	K020784	000
04037691454467	K020784	000
04037691404592	K020784	000
04037691063584	K020784	000
04037691168951	K020784	000
04037691144528	K020784	000
04037691168845	K020784	000
04037691201634	K020784	000
04037691137797	K020784	000
04037691172064	K020784	000
04037691168517	K020784	000
04037691281681	K020784	000