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 K241370
Device Name Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)
Applicant
ABBOTT MEDICAL
14901 Deveau Pl.
Minnetonka,  MN  55345
Applicant Contact Alyssa Timmers
Correspondent
ABBOTT MEDICAL
14901 Deveau Pl.
Minnetonka,  MN  55345
Correspondent Contact Alyssa Timmers
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/14/2024
Decision Date 06/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-