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 Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K925485
Device Name VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER
Applicant
Vas-Cath, Inc.
2380 Tedlo St.
Mississauga, Ontario,  CA L5A 3V3
Applicant Contact ANGELA J ACITO
Correspondent
Vas-Cath, Inc.
2380 Tedlo St.
Mississauga, Ontario,  CA L5A 3V3
Correspondent Contact ANGELA J ACITO
Regulation Number870.1250
Classification Product Code
LIT  
Date Received10/30/1992
Decision Date 03/10/1994
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
-
-