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 Catheter, Percutaneous
510(k) Number K933033
Device Name GUIDING CATHETER HEMOSTASIS VALVE CAP
Applicant
Arrow Intl., Inc.
P.O. Box 12888
3000 Bernville Rd.
Reading,  PA  19612
Applicant Contact THOMAS NICKEL
Correspondent
Arrow Intl., Inc.
P.O. Box 12888
3000 Bernville Rd.
Reading,  PA  19612
Correspondent Contact THOMAS NICKEL
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/22/1993
Decision Date 09/10/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-