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, Roller Type
510(k) Number K881780
Device Name VASCUCARE ANGIOPUMP
Applicant
Vascucare, Inc.
40 Ramland Rd. S.
Orangeburg,  NY  10962
Applicant Contact WAYNE E LIPSON
Correspondent
Vascucare, Inc.
40 Ramland Rd. S.
Orangeburg,  NY  10962
Correspondent Contact WAYNE E LIPSON
Regulation Number870.4370
Classification Product Code
DWB  
Date Received04/26/1988
Decision Date 09/28/1988
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
-
-