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Spire Biomedical, Inc.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K073092 DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,MSD2008-01-29 View
510(k) K073093 DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,MSD2008-01-22 View
510(k) K063441 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55MSD2007-02-12 View
510(k) K063431 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40MSD2007-01-29 View
510(k) K062435 REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERSNFK2006-12-05 View
510(k) K060288 RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERSMSD2006-09-01 View
510(k) K060155 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPSMSD2006-05-09 View
510(k) K042858 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPSMSD2004-12-03 View
510(k) K041559 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55MSD2004-07-30 View
510(k) K040509 ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40MSD2004-04-19 View
510(k) K032061 DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NHMSD2003-12-23 View
510(k) K022644 RETRO REPAIR KIT, MODEL PRRK5NFK2002-11-06 View
510(k) K022620 SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRTFKA2002-10-11 View
510(k) K022000 POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)MSD2002-07-19 View
510(k) K021212 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPSMSD2002-05-17 View
510(k) K013160 POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETERMSD2002-04-11 View
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