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, Percutaneous
510(k) Number K192525
FOIA Releasable 510(k) K192525
Device Name 087 Balloon Guide Catheter System
Applicant
Q'Apel Medical, LLC
330 Wilshire Blvd.
Santa Monica,  CA  90401
Applicant Contact Ken Peartree
Correspondent
Lakeshore Medical Device Consulting, LLC
128 Blye Hill Landing
Newbury,  NH  03255
Correspondent Contact Michele Lucey
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/13/2019
Decision Date 10/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-