DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR

Needle, Conduction, Anesthetic (w/wo Introducer)

KYPHON, INC.

The following data is part of a premarket notification filed by Kyphon, Inc. with the FDA for Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular.

Pre-market Notification Details

Device IDK073516
510k NumberK073516
Device Name:DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant KYPHON, INC. 1221 CROSSMAN AVE. Sunnyvale,  CA  94089
ContactPamela Segale
CorrespondentPamela Segale
KYPHON, INC. 1221 CROSSMAN AVE. Sunnyvale,  CA  94089
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-14
Decision Date2008-02-21
Summary:summary

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