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 K810962
Device Name ARROW VESSEL CATHETER. KIT W/20GA INDWEL
Applicant
ARROW INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ARROW INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/08/1981
Decision Date 04/29/1981
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
Recalls CDRH Recalls
-
-