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 Anesthesia Conduction Kit
510(k) Number K121403
Device Name CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
Applicant
TELEFLEX, INC.
2400 BERNVILLE ROAD
READING,  PA  19605
Applicant Contact PAUL AMUDALA
Correspondent
TELEFLEX, INC.
2400 BERNVILLE ROAD
READING,  PA  19605
Correspondent Contact PAUL AMUDALA
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received05/10/2012
Decision Date 06/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-