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510(k) K921856

TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. by Schneider Intl., Ltd. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1992
Date Received
April 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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  • K920157 — SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER (March 16, 1992)
  • K915349 — PTA BALLOON CATHETER (February 11, 1992)
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