• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name introducer, catheter
510(k) Number K091367
Device Name GDS-DCS
Applicant
GUIDED DELIVERY SYSTEMS
2355 calle de luna
santa clara,  CA  95054
Applicant Contact bonnie mcinerney
Correspondent
GUIDED DELIVERY SYSTEMS
2355 calle de luna
santa clara,  CA  95054
Correspodent Contact bonnie mcinerney
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/08/2009
Decision Date 11/05/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-