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510(k) K821684

Device
MCSCP8PS WITH 'Y' HUB
Applicant
MEDICAL COMPONENTS, INC.
510(k) number
K821684
Product code
LFJ  
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-24
Date received
1982-06-08
Regulation
876.5540
Classification name
Catheter, Subclavian
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LFJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920780MEDSURG INSERTION TRAYMedsurg Industries, Inc.1994-08-19
K925819AKCESS0CATH KITAkcess Medical Products, Inc.1994-08-02
K925818AKCESS-CATHAkcess Medical Products, Inc.1994-04-05
K913468ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAYCook, Inc.1994-03-24
K931120COAXIAL ACUTE CATHETERAkcess Medical Products, Inc.1994-01-14
K920634SPLITTABLE SHEATH INTRODUCER SETAkcess Medical Products, Inc.1994-01-14
K914162VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERSVas-Cath, Inc.1993-07-01
K915423HEMO-CATH SILICONE ACCESS CATHETERMedical Components, Inc.1993-02-02
K914826AKCESS-CATH KITAkcess Medical Products, Inc.1992-04-10
K910501PERMANENT SILICONE CATHETERSAkcess Medical Products, Inc.1991-04-29
K905080MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETERKendall Healthcare Products Co. Div.Of Tyco Health1991-01-31
K904139SINGLE LUMEN CATHETER KITSAkcess Medical Products, Inc.1990-12-04
K904140SINGLE LUMEN CATHETERS, MODIFICATIONAkcess Medical Products, Inc.1990-11-27
K901133DURACATHImpra, Inc.1990-06-08
K901061SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000Akcess Medical Products, Inc.1990-05-22

Legacy Summary#

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FDA Review#

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