SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA)

K911196 · Schneider Intl., Ltd. · LIT · Jun 10, 1991 · Cardiovascular

Device Facts

Record IDK911196
Device NameSCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA)
ApplicantSchneider Intl., Ltd.
Product CodeLIT · Cardiovascular
Decision DateJun 10, 1991
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.1250
Device ClassClass 2

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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