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510(k) K822096

Device
CHEMOTHERAPY INFUSION CATHETER
Applicant
AMERICAN HEYER SCHULTE
510(k) number
K822096
Product code
JCY  
Decision
Substantially Equivalent (SESE)
Decision date
1983-04-12
Date received
1982-07-16
Regulation
878.4200
Classification name
Catheter, Infusion
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
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 JCY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863982VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAYVas-Cath of Canada , Ltd.1986-10-24
K840324SILICONE SUMP DRAIN 20 & 40 FRENCHSuperior Plastic Products Corp.1984-04-25
K834615TRIPLE LUMEN INFUSIONCATHETERS-Medical Components, Inc.1984-02-14
K831453SILCATH CENTRAL CATHETER TRAY W/18 GAArgon Medical Corp.1983-07-28
K831451SILCATH CENTRAL CATHETER TRAY SIZE-Argon Medical Corp.1983-06-08
K813606SILICONE ELASTOMER INFUSION CATHETERQuest Medical, Inc.1982-01-18
K791372JELCO & KVO CATHETER PLACEMENT UNITJelco Laboratories1979-09-12
K771861CATHETER, CEBTRAL VENOUS, 2N1501Travenol Laboratories, S.A.1977-11-28
K760760CATHETER, INTRAVASCULAR (ARGYLE IV SK)Sherwood Medical Industries1976-12-09
K760380INTRAVENOUS TRANSFER SET (INTRAFIX)B. Braun Instruments1976-11-02
K760381BLOOD TRANSFUSION SET (SANGOFIX)B. Braun Instruments1976-11-02
K760390CATHETER, VEIN (BRAUNULA T)B. Braun Instruments1976-11-02
K760391CATHETER, VEIN (BRAUNULA)B. Braun Instruments1976-11-02

Legacy Summary#

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FDA Review#

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