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, Thrombus Retriever
510(k) Number K222786
Device Name 072 Aspiration System
Applicant
Q'Apel Medical, Inc.
4245 Technology Dr.
Fremont,  CA  94538
Applicant Contact Kim Ky
Correspondent
Q'Apel Medical, Inc.
4245 Technology Dr.
Fremont,  CA  94538
Correspondent Contact Kim Ky
Regulation Number870.1250
Classification Product Code
NRY  
Date Received09/15/2022
Decision Date 08/25/2023
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
Recalls CDRH Recalls
-
-