6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING

Catheter, Percutaneous

BIOCOMPATIBLES CARDIOVASCULAR, INC.

The following data is part of a premarket notification filed by Biocompatibles Cardiovascular, Inc. with the FDA for 6 French, 7 French, And 8 French Guiding Catheters With Phosphorylcholine (pc) Polymer Coating.

Pre-market Notification Details

Device IDK962717
510k NumberK962717
Device Name:6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING
ClassificationCatheter, Percutaneous
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 CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-12
Decision Date1997-02-12
Summary:summary

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