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 Dr., Unit 33
Mississauga, Ontario,  CA L4W-4T7
Applicant Contact KRIS SHAH
Correspondent
Baylis Medical Co., Inc.
5160 Explorer Dr., 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-