510(k) Report

Devices descending from K021212

10 later devices reach 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated… through their predicates, nearest generation first.

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