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 Transducer, Ultrasonic, Diagnostic
510(k) Number K073623
Device Name ATLANTIS 018 PERIPHERAL IMAGING CATHETER
Applicant
Boston Scientific Corp
47900 Bayside Pkwy.
Fremont,  CA  94538 -6515
Applicant Contact EMILLY TOJIMA
Correspondent
Boston Scientific Corp
47900 Bayside Pkwy.
Fremont,  CA  94538 -6515
Correspondent Contact EMILLY TOJIMA
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
OBJ  
Date Received12/26/2007
Decision Date 03/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-