Medical Device Manufacturer · US , Westminster , CO

Surefire Medical, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2011

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Surefire Medical, Inc. Cardiovascular ✕

10 devices

1-10 of 10

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