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, Neurovasculature
510(k) Number K213451
Device Name Spartan MC 0165
Applicant
Spartan Micro
3167 Skyway Ct.
Fremont,  CA  94539
Applicant Contact Gary Avedovech
Correspondent
Spartan Micro
3167 Skyway Ct.
Fremont,  CA  94539
Correspondent Contact Gary Avedovech
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Codes
DQY   KRA  
Date Received10/26/2021
Decision Date 11/22/2021
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
-
-