Medical Device Manufacturer · US , Bedford , MA

Spire Biomedical, Inc. - FDA 510(k) Cleared Devices

16 submissions · 12 cleared · Since 2002
16
Total
12
Cleared
0
Denied

Spire Biomedical, Inc. has 12 FDA 510(k) cleared gastroenterology & urology devices. Based in Bedford, US.

Historical record: 12 cleared submissions from 2002 to 2008.

Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Spire Biomedical, Inc.

16 devices
1-12 of 16
Cleared Jan 29, 2008
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS...
K073092 · MSD
Gastroenterology & Urology · 89d
Cleared Jan 22, 2008
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS...
K073093 · MSD
Gastroenterology & Urology · 82d
Cleared Feb 12, 2007
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28,...
K063441 · MSD
Gastroenterology & Urology · 90d
Cleared Jan 29, 2007
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24,...
K063431 · MSD
Gastroenterology & Urology · 77d
Cleared Dec 05, 2006
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
K062435 · NFK
Gastroenterology & Urology · 106d
Cleared Sep 01, 2006
RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS
K060288 · MSD
Gastroenterology & Urology · 207d
Cleared May 09, 2006
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH...
K060155 · MSD
Gastroenterology & Urology · 109d
Cleared Dec 03, 2004
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS
K042858 · MSD
Gastroenterology & Urology · 49d
Cleared Jul 30, 2004
55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL...
K041559 · MSD
Gastroenterology & Urology · 50d
Cleared Apr 19, 2004
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28,...
K040509 · MSD
Gastroenterology & Urology · 52d
Cleared Dec 23, 2003
DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH,...
K032061 · MSD
Gastroenterology & Urology · 173d
Cleared Nov 06, 2002
RETRO REPAIR KIT, MODEL PRRK5
K022644 · NFK
Gastroenterology & Urology · 90d
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