SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A

Dislodger, Stone, Biliary

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Single Use 3-lumen Extraction Balloon V, Model V B-v233p-a,b-v233p-b,b-v433p-a,b-v433p-b, Bv243q-a, B-v243q-b, B-v443q-a.

Pre-market Notification Details

Device IDK091495
510k NumberK091495
Device Name:SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A
ClassificationDislodger, Stone, Biliary
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
ContactStacy Abbatiello
CorrespondentStacy Abbatiello
OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
Product CodeLQR  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-20
Decision Date2009-09-03
Summary:summary

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