HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING

Wire, Guide, Catheter

BIOCOMPATIBLES CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Biocompatibles Cardiovascular, Inc. with the FDA for Hunter 0.014 Inch Super Soft / Hunter O.014 Inch Soft Guide Wires W/thromboresistant Pc Coating.

Pre-market Notification Details

Device IDK970938
510k NumberK970938
Device Name:HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING
ClassificationWire, Guide, Catheter
Applicant BIOCOMPATIBLES CARDIOVASCULAR, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville,  MD  20852
ContactNancy F Teague
CorrespondentNancy F Teague
BIOCOMPATIBLES CARDIOVASCULAR, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville,  MD  20852
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-13
Decision Date1997-11-17
Summary:summary

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