FDA.reportPublic FDA data

510(k) K920891

Device
Roadrunner(tm) Wire Guide, Modification
Applicant
COOK, INC.
510(k) number
K920891
Product code
DQX
Decision
Substantially Equivalent (SESE)
Decision date
1992-12-21
Date received
1992-02-24
Regulation
870.1330
Classification name
Wire, Guide, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
APRIL LAVENDER
Address
925 S. Curry Pike P.O. Box 489 Bloomington IN US 47402 47402

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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