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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 K014075
Device Name BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
Applicant
BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, UNIT 33
MISSISSAUGA, ONTARIO,  CA L4W-4T7
Applicant Contact KRIS SHAH
Correspondent
BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, UNIT 33
MISSISSAUGA, ONTARIO,  CA L4W-4T7
Correspondent Contact KRIS SHAH
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/11/2001
Decision Date 03/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-