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510(k) K771219

Device
BRONCHO-CATH
Applicant
MALLINCKRODT CRITICAL CARE
510(k) number
K771219
Product code
BTS  
Decision
Substantially Equivalent (SESE)
Decision date
1977-08-04
Date received
1977-07-05
Regulation
868.5720
Classification name
Tube, Bronchial (w/wo Connector)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
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 BTS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K953963RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATIONRusch, Inc.1995-11-27
K951091RUSCH ENDOBRONCHIAL TUBE SETSRusch Intl.1995-06-08
K902116MODIFIED ENDOBRONCHIAL TUBEConcord/Portex1990-08-03
K834565ENDOBRONCHIAL TWIN LUMEN TUBEPortex, Inc.1984-01-17
K833297BRONCHOSCOPY TUBE W/ULTRA LOCUFFSurgitek1983-12-27

Legacy Summary#

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FDA Review#

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