Spectranetics Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Spectranetics Corp. - FDA 510(k) Cleared Devices
Recent clearances: LEXICONTURE MECHANICAL DILATOR SHEATH SET, 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035, 8FR TURBO - TANDEM SYSTEM
24
Total
24
Cleared
0
Denied
Spectranetics Corp. has 24 FDA 510(k) cleared cardiovascular devices. Based in Colorado Springs, US.
Historical record: 24 cleared submissions from 1999 to 2014.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Spectranetics Corp.
24 devices
Cleared
Apr 09, 2014
LEXICONTURE MECHANICAL DILATOR SHEATH SET
Cardiovascular
90d
Cleared
Jan 25, 2013
2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
Cardiovascular
63d
Cleared
Oct 17, 2011
8FR TURBO - TANDEM SYSTEM
Cardiovascular
94d
Cleared
Mar 26, 2010
TORQMAX SHEATH GRIP ACCESSORY
Cardiovascular
158d
Cleared
Jan 25, 2010
TURBO-TANDEM SYSTEM MODEL 472-110
Cardiovascular
26d
Cleared
Nov 02, 2009
SPECTRANETICS VISISHEATH DILATOR SHEATH
Cardiovascular
89d
Cleared
Sep 04, 2009
SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS
Cardiovascular
30d
Cleared
Jul 01, 2009
SPECTRANETICS TURBO-TANDEM SYSTEM
Cardiovascular
58d
Cleared
May 04, 2009
CROSS-PILOT TURBO ELITE SUPPORT CATHETER
Cardiovascular
33d
Cleared
Dec 11, 2008
SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER
Cardiovascular
98d
Cleared
Dec 10, 2008
SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS
Cardiovascular
97d
Cleared
Dec 04, 2007
SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066
Cardiovascular
68d