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510(k) K911196

SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA) by Schneider Intl., Ltd. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1991
Date Received
March 18, 1991
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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  • K925804 — SCHNEIDER HYDRO-SIL GUIDEWIRE (February 12, 1993)
  • K924591 — SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER (December 8, 1992)
  • K921856 — TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. (July 21, 1992)
  • K921943 — SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL (June 17, 1992)
  • K920157 — SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER (March 16, 1992)
  • K915349 — PTA BALLOON CATHETER (February 11, 1992)

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