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510(k) K981061

Device
INTRAVASCULAR RETRIEVAL DEVICE
Applicant
MED INSTITUTE, INC.
510(k) number
K981061
Product code
GCC  
Decision
Substantially Equivalent (SESE)
Decision date
1998-05-26
Date received
1998-03-23
Regulation
878.4200
Classification name
Dilator, Catheter
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
NEAL FEARNOT
Address
P.O.Box 2402 West Lafayette IN US 47906 47906

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GCC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K922354BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SETMed Institute, Inc.1992-07-30
K902502BYRD STAINLESS STEEL DILATORMedical Engineering and Development Institute1990-08-07
K893480BYRD EXTRACTOR SETMedical Engineering and Development Institute1989-06-23
K820865VAN-TEC FASCIAL DILATORVan-Tec, Inc.1982-05-05

Legacy Summary#

summary

FDA Review#

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