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 K923947
Device Name MEADOX SURGIMED BALLOON CATHETER
Applicant
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07436
Applicant Contact PATRICIA CHRISTIAN
Correspondent
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07436
Correspondent Contact PATRICIA CHRISTIAN
Regulation Number870.1250
Classification Product Code
LIT  
Date Received08/05/1992
Decision Date 09/30/1993
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
-
-