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 Syringe, Balloon Inflation
510(k) Number K853136
Device Name MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)
Applicant
E.A. Fischione Instrument Mfg.
216 Red Oak Dr.
Pittsburgh,  PA  15239
Applicant Contact PAUL E FISCHIONE
Correspondent
E.A. Fischione Instrument Mfg.
216 Red Oak Dr.
Pittsburgh,  PA  15239
Correspondent Contact PAUL E FISCHIONE
Regulation Number870.1650
Classification Product Code
MAV  
Date Received07/26/1985
Decision Date 12/03/1985
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
-
-