# K063431: 15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 - Pathway: 510(k) (Traditional) - Applicant: Spire Biomedical, Inc. - Decided: Jan 29, 2007 after 77 days - Product code: MSD (Catheter, Hemodialysis, Implanted) - Device class: 2 - Regulation: 21 CFR 876.5540 - Recalls of this device: 48 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K925626 (1993). 6 ancestors in all. No later device cites it as a predicate yet. 0 of 7 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K060155: 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips, Spire Biomedical, Inc. (2006) Summary page 3. - K925626: Maxima Plus Hollow Fiber Oxygenator, Medtronic Vascular (1993) Summary page 3. - K933586: Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive Surface, Medtronic Vascular (1994) Summary page 3. - K970906: Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus Multiparameter Sensor, Diametrics Medical, Ltd. (1997) Summary page 3. - P900043: Palmaz-Schatz (TM) Balloon Expandable Stent, Cordis Corp. (1994) Summary page 3. ## Recalls of this device - Oct 23, 2009 · Not classified · Z-0288-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0289-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0290-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0299-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0301-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0302-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0304-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0306-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0309-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0311-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0312-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0294-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0295-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0296-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0297-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0300-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0303-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0307-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0308-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0314-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0316-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0317-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0318-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0319-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0321-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0330-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0291-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0292-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0293-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0298-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0305-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0310-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0313-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0315-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0320-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0322-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0323-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0324-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0325-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0327-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0328-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0332-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0334-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0335-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0329-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0331-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0333-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0326-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi ## Indications for use Spire Biomedical Inc's Decathlon Gold, Coated Twin Lumen Chronic Hemodialysis Catheter with separated funnel tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda® End point Bonded Heparin Coating to reduce clotting is supported by in-vitro testing. Catheters longer than 40cm are intended for femoral vein insertion. Source page: https://510kreport.com/device/K063431 Methodology: https://510kreport.com/methodology