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510(k) K920157

SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER by Schneider Intl., Ltd. — Product Code DXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1992
Date Received
January 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implantable Pacemaker Pulse-Generator
Device Class
Class III
Regulation Number
870.3610
Review Panel
CV
Submission Type

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  • K926271 — SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO (June 7, 1993)
  • K925804 — SCHNEIDER HYDRO-SIL GUIDEWIRE (February 12, 1993)
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  • K921856 — TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. (July 21, 1992)
  • K921943 — SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL (June 17, 1992)
  • K915349 — PTA BALLOON CATHETER (February 11, 1992)
  • K914009 — SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER (December 6, 1991)

Other clearances for product code DXY

  • K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (November 10, 1999)
  • K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS (August 29, 1997)
  • K945627 — PIKOS LP 01, PIKOS LP E01 (March 4, 1996)
  • K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) (December 15, 1995)
  • K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) (December 15, 1995)
  • K953417 — MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (September 29, 1995)
  • K952328 — NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (September 29, 1995)
  • K952364 — OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (September 1, 1995)
  • K940039 — PELLETHANE 75D (July 12, 1995)
  • K946188 — CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (May 15, 1995)