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510(k) K841410

BUSH NECK W/TAP by Warne Surgical Products, Ltd. — Product Code DRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1984
Date Received
April 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Cardiac, External
Device Class
Class II
Regulation Number
870.5200
Review Panel
CV
Submission Type

Other clearances by Warne Surgical Products, Ltd.

  • K850694 — WSP CODE 4310 STRESSCATH (May 17, 1985)
  • K850696 — WSP CODE 4300 DIOMASTER DIAGNOSTIC (May 17, 1985)
  • K850695 — WSP CODE 4301 DIOMASTER THERAPEUTIC (May 16, 1985)
  • K850693 — WSP CODE 4315 PADTEST (May 10, 1985)
  • K841511 — HAEMATURIA CATHETERS (July 12, 1984)
  • K840687 — KIDNEY TRANSPLANT CATHETER (June 7, 1984)
  • K841409 — BUSH NECK W/PLUG (April 18, 1984)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)
  • K840702 — SECURE W/25MM DIAM. SHEATH & ADHESIVE (March 22, 1984)

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  • K211289 — RMU-2000 Automated Chest Compression System (November 9, 2021)
  • K173553 — LUCAS 3 Chest Compression System (February 8, 2018)
  • K161768 — LUCAS 3 Chest Compression System (November 9, 2016)
  • K153628 — ROSC-U Mini Chest Compressor (RMCC) (January 30, 2016)
  • K141809 — RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM (October 27, 2014)
  • K112998 — AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 (March 15, 2012)
  • K102068 — MINIATURIZE CHEST COMPRESSOR (MCC) (November 16, 2010)
  • K090422 — LUCAS 2 (June 17, 2009)
  • K072527 — AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (March 19, 2008)