CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM

Port & Catheter, Implanted, Subcutaneous, Intravascular

CATHETER TECHNOLOGY CORP.

The following data is part of a premarket notification filed by Catheter Technology Corp. with the FDA for Cath-tech Port Implantable Vascular Access System.

Pre-market Notification Details

Device IDK880571
510k NumberK880571
Device Name:CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant CATHETER TECHNOLOGY CORP. 3385 WEST 1820 SOUTH Salt Lake City,  UT  84104
ContactJack Speer
CorrespondentJack Speer
CATHETER TECHNOLOGY CORP. 3385 WEST 1820 SOUTH Salt Lake City,  UT  84104
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-10
Decision Date1988-03-04

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