0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER 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 0.014 Inch Extra Long Floppy And 0.014 Extra Long Intermediate Guide Wires With Phosphorylcholine (pc) Polymer Coating.

Pre-market Notification Details

Device IDK962266
510k NumberK962266
Device Name:0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER 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 Received1996-06-12
Decision Date1996-09-10
Summary:summary

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