Spire Biomedical, Inc. - FDA 510(k) Cleared Devices
16
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spire Biomedical, Inc. Gastroenterology & Urology ✕
16 devices
Cleared
Jan 29, 2008
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS...
Gastroenterology & Urology
89d
Cleared
Jan 22, 2008
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS...
Gastroenterology & Urology
82d
Cleared
Feb 12, 2007
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28,...
Gastroenterology & Urology
90d
Cleared
Jan 29, 2007
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24,...
Gastroenterology & Urology
77d
Cleared
Dec 05, 2006
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
Gastroenterology & Urology
106d
Cleared
Sep 01, 2006
RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS
Gastroenterology & Urology
207d
Cleared
May 09, 2006
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH...
Gastroenterology & Urology
109d
Cleared
Dec 03, 2004
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS
Gastroenterology & Urology
49d
Cleared
Jul 30, 2004
55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL...
Gastroenterology & Urology
50d
Cleared
Apr 19, 2004
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28,...
Gastroenterology & Urology
52d
Cleared
Dec 23, 2003
DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH,...
Gastroenterology & Urology
173d
Cleared
Nov 06, 2002
RETRO REPAIR KIT, MODEL PRRK5
Gastroenterology & Urology
90d