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, Angioplasty, Peripheral, Transluminal
510(k) Number K934191
Device Name NEW BLUE MAX BALLOON DILATATION CATHETER
Applicant
Boston Scientific Corp
480 Pleasant St.
Watertown,  MA  02472
Applicant Contact PAMELA L CADORETTE
Correspondent
Boston Scientific Corp
480 Pleasant St.
Watertown,  MA  02472
Correspondent Contact PAMELA L CADORETTE
Regulation Number870.1250
Classification Product Code
LIT  
Date Received08/26/1993
Decision Date 12/09/1993
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
-
-