KSEA DEPLOYABLE CARDIOVASCULAR CLAMP

Clamp, Vascular

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Deployable Cardiovascular Clamp.

Pre-market Notification Details

Device IDK014277
510k NumberK014277
Device Name:KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
ClassificationClamp, Vascular
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactJames A Lee
CorrespondentJames A Lee
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-27
Decision Date2002-12-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551168271 K014277 000
04048551168257 K014277 000
04048551168240 K014277 000
04048551168233 K014277 000
04048551168226 K014277 000
04048551168103 K014277 000
04048551168080 K014277 000

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