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510(k) K912317

SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH by Schneider Intl., Ltd. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1991
Date Received
May 24, 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

Other clearances by Schneider Intl., Ltd.

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  • K931577 — SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI (June 23, 1993)
  • K926003 — SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER (June 7, 1993)
  • K926271 — SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO (June 7, 1993)
  • 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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