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 introducer, catheter
510(k) Number K102948
Device Name TORFLEX TRANSSEPTAL GUIDING SHEATH
Applicant
BAYLIS MEDICAL CO., INC.
2645 MATHESON BLVD. E
MISSISSAUGA, ONTARIO,  CA L4W 5S4
Applicant Contact MEGHAL KHAKHAR
Correspondent
BAYLIS MEDICAL CO., INC.
2645 MATHESON BLVD. E
MISSISSAUGA, ONTARIO,  CA L4W 5S4
Correspondent Contact MEGHAL KHAKHAR
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Codes
DQY   DRE  
Date Received10/05/2010
Decision Date 04/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-