FDA.reportPublic FDA data

510(k) K020890

Device
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
Applicant
St Jude Medical
510(k) number
K020890
Product code
DQO
Decision
Substantially Equivalent (SESE)
Decision date
2002-04-17
Date received
2002-03-19
Regulation
870.1200
Classification name
Catheter, Intravascular, Diagnostic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KIRK S HONOUR
Address
14901 Deveau Pl. Minnetonka MN US 55345 55345

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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