510(k) Report

Devices descending from K002902

11 later devices reach Tandem-Cath 10 FR. Catheter System, Model Multiple Code Numbers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041006Tandem-Cath Hemodialysis Catheter, Model 10 FRKendall20040—
+1K022644Retro Repair Kit, Model PRRK5Spire Biomedical, Inc.20021—
+1K022000Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and…Spire Biomedical, Inc.20029—
+2K062435Repair Kit for Xpresso, Decathlon, and Alta LR CathetersSpire Biomedical, Inc.20060—
+2K060288Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc.20060—
+2K043292HemocathMed-Conduit, Inc.20053—
+2K04155955CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…Spire Biomedical, Inc.20041—
+2K022620Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and XrikrtSpire Biomedical, Inc.20020—
+3K062901Hemocath IIMed-Conduit, Inc.20072—
+4K071202Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc.20071—
+5K091760Dermaport Ported Vascular Access System (Pvas)Dermaport, Inc.20090—