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 System, Balloon, Intra-Aortic And Control
510(k) Number K833632
Device Name ARIES MEDICAL MODEL 700
Applicant
Aries Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Aries Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3535
Classification Product Code
DSP  
Date Received10/17/1983
Decision Date 05/16/1984
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
-
-