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 Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K912604
Device Name SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
Applicant
Aries Medical, Inc.
12 Elizabeth Dr.
Chelmsford,  MA  01824
Applicant Contact JOSEPH CURTIS
Correspondent
Aries Medical, Inc.
12 Elizabeth Dr.
Chelmsford,  MA  01824
Correspondent Contact JOSEPH CURTIS
Regulation Number870.4360
Classification Product Code
KFM  
Date Received05/31/1991
Decision Date 10/28/1991
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
-
-