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 Introducer, Catheter
510(k) Number K202141
Device Name Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
Applicant
Argon Medical Devices, Inc.
1445 Flat Creek Rd.
Athens,  TX  75751
Applicant Contact Amy Clendening-Wheeler
Correspondent
Argon Medical Devices, Inc.
1445 Flat Creek Rd.
Athens,  TX  75751
Correspondent Contact Amy Clendening-Wheeler
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/31/2020
Decision Date 01/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-