Spire Biomedical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,, DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,, 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55
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