Spire Biomedical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K073092DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32,January 29, 2008
K073093DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEJanuary 22, 2008
K06344115.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALFebruary 12, 2007
K06343115.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, January 29, 2007
K062435REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERSDecember 5, 2006
K060288RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERSSeptember 1, 2006
K06015515.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPSMay 9, 2006
K04285855CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPSDecember 3, 2004
K04155955CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RJuly 30, 2004
K040509ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35April 19, 2004
K032061DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31December 23, 2003
K022644RETRO REPAIR KIT, MODEL PRRK5November 6, 2002
K022620SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRTOctober 11, 2002
K022000POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HJuly 19, 2002
K02121224CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPSMay 17, 2002
K013160POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETERApril 11, 2002