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 Sleeve, Limb, Compressible
510(k) Number K234155
Device Name Nimbl (model PD08-N1)
Applicant
Tactile Medical
3701 Wayzata Blvd.
Suite 300
Minneapolis,  MN  55416
Applicant Contact Vishal Agarwal
Correspondent
The Tamarack Group-Mpls, LLC
23730 Lawtonka Dr.
Shorewood,  MN  55331
Correspondent Contact Charmaine Dwyer
Regulation Number870.5800
Classification Product Code
JOW  
Date Received12/29/2023
Decision Date 06/21/2024
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
-
-