• 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 System, Balloon, Intra-Aortic And Control
510(k) Number K000729
Device Name ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
Applicant
ARROW INTL., INC.
9 PLYMOUTH ST.
EVERETT,  MA  02149
Applicant Contact WILLIAM PAQUIN
Correspondent
ARROW INTL., INC.
9 PLYMOUTH ST.
EVERETT,  MA  02149
Correspondent Contact WILLIAM PAQUIN
Regulation Number870.3535
Classification Product Code
DSP  
Date Received03/06/2000
Decision Date 05/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-