Surefire Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Surefire Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Surefire Spark Infusion System
10
Total
10
Cleared
0
Denied
Surefire Medical, Inc. has 10 FDA 510(k) cleared cardiovascular devices. Based in Westminster, US.
Historical record: 10 cleared submissions from 2011 to 2018.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Surefire Medical, Inc.
10 devices
Cleared
Apr 03, 2018
Surefire Spark Infusion System
Cardiovascular
19d
Cleared
May 17, 2017
Surefire Precision Infusion System
Cardiovascular
8d
Cleared
Sep 21, 2016
Surefire Guiding Catheter
Cardiovascular
29d
Cleared
Mar 11, 2016
Surefire Infusion System
Cardiovascular
2d
Cleared
Jan 12, 2015
Surefire Infusion System 021
Cardiovascular
25d
Cleared
Feb 26, 2014
SUREFIRE GUIDING CATHETER
Cardiovascular
50d
Cleared
Sep 17, 2012
SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
Cardiovascular
31d
Cleared
Jun 14, 2012
SUREFIRE HI-FLOW MICROCATHETER
Cardiovascular
7d
Cleared
Feb 23, 2012
SUREFIRE GUIDE SHEATH
Cardiovascular
65d
Cleared
Jun 24, 2011
SUREFIRE INFUSION CATHETER SYSTEM
Cardiovascular
127d