FDA.reportPublic FDA data

510(k) K022620

Device
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
Applicant
Spire Biomedical, Inc.
510(k) number
K022620
Product code
FKA
Decision
Substantially Equivalent (SESE)
Decision date
2002-10-11
Date received
2002-08-07
Regulation
876.5540
Classification name
Dilator, Vessel
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
DONALD FICKETT
Address
One Patriots Park Bedford MA US 01730 01730

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FKA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914210VAS-CATH DUALATOR(TM) VESSEL DILATORVas-Cath, Inc.1993-07-01
K910502VESSEL DILATORSAkcess Medical Products, Inc.1991-04-29