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Spire Biomedical, Inc.

16 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, (K073092)Spire Biomedical, Inc.2008-01-29
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, (K073093)Spire Biomedical, Inc.2008-01-22
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 (K063441)Spire Biomedical, Inc.2007-02-12
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 (K063431)Spire Biomedical, Inc.2007-01-29
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS (K062435)Spire Biomedical, Inc.2006-12-05
RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS (K060288)Spire Biomedical, Inc.2006-09-01
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (K060155)Spire Biomedical, Inc.2006-05-09
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS (K042858)Spire Biomedical, Inc.2004-12-03
55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 (K041559)Spire Biomedical, Inc.2004-07-30
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 (K040509)Spire Biomedical, Inc.2004-04-19
DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH (K032061)Spire Biomedical, Inc.2003-12-23
RETRO REPAIR KIT, MODEL PRRK5 (K022644)Spire Biomedical, Inc.2002-11-06
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT (K022620)Spire Biomedical, Inc.2002-10-11
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) (K022000)Spire Biomedical, Inc.2002-07-19
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (K021212)Spire Biomedical, Inc.2002-05-17
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER (K013160)Spire Biomedical, Inc.2002-04-11

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