Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name wire, guide, catheter
510(K) Number K122506
Models SHF-5065-ACCESS, SHF-5065-STRAIGHT
Device Name SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
Applicant
SUREFIRE MEDICAL, INC
12415 sw 136 avenue
unit 3
miami,  FL  33186
Contact mario arbesu
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/17/2012
Decision Date 09/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
-
-