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510(k) K781665

Device
TUBE, LEATHERMAN/IMBRUCE
Applicant
NATIONAL CATHETER CO. DIV. MALLINCKRODT
510(k) number
K781665
Product code
GBA  
Decision
Substantially Equivalent (SESE)
Decision date
1978-12-15
Date received
1978-09-28
Regulation
878.4200
Classification name
Catheter, Balloon Type
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GBA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K861877BYRON WORD BARTHOLIAN GLAND CATHETERByron Medical1986-05-30
K802025BALLOON RETENTION CHEST CATHETERLoseff Medical Designers, Ltd.1980-09-26
K790444ELECATH MULTI-PURPOSE ARTERIAL SURGERElectro-Catheter Corp.1979-06-11
K781772CATHETER, TRANSLUMINAL BALLOONMedi-Tech, Inc.1979-03-06

Legacy Summary#

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FDA Review#

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