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 Dilator, Vessel
510(k) Number K022620
Device Name SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
Applicant
SPIRE BIOMEDICAL, INC.
ONE PATRIOTS PARK
BEDFORD,  MA  01730 -2396
Applicant Contact DONALD FICKETT
Correspondent
SPIRE BIOMEDICAL, INC.
ONE PATRIOTS PARK
BEDFORD,  MA  01730 -2396
Correspondent Contact DONALD FICKETT
Regulation Number876.5540
Classification Product Code
FKA  
Date Received08/07/2002
Decision Date 10/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-