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510(k) K802258

STOPCOCK 2-WAY, 3-WAY & 4-WAY by Stanco Medical, Inc. — Product Code FMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
September 16, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stopcock, I.V. Set
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Stanco Medical, Inc.

  • K810642 — ATRIAL-VENTRICULAR PACING ELECTRODE KIT (April 8, 1981)
  • K810643 — UNIVERSAL PACING ELECTRODE KIT (April 8, 1981)
  • K802289 — PERICARDIOCENTESIS KIT (November 26, 1980)
  • K802287 — RIGHT ATRIAL LINE KIT (November 20, 1980)
  • K802288 — SWAN GANZ CATHETER PLACEMENT KIT (November 20, 1980)
  • K802259 — TRANSVENOUS PACEMAKER ELECTRODE KIT (October 23, 1980)
  • K802290 — REGIONAL INTRAVENOUS ANESTHESIA KIT (October 17, 1980)
  • K802327 — SHEATH DILATOR SET (October 10, 1980)
  • K802328 — DISP. TOUGY-BORST TYPE ADAPTOR W/PORT (October 10, 1980)
  • K802326 — PRESSURE MONITORING LINES (October 10, 1980)

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  • K211204 — SafePort(TM) Manifold (or Stopcock) (September 15, 2022)
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  • K190539 — TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal (October 22, 2019)
  • K190489 — Elcam Stopcocks and Manifolds (April 23, 2019)
  • K172266 — Dynarex Three-Way Stopcock (March 14, 2018)
  • K141254 — ELCAM STOPCOCKS AND MANIFOLDS (July 30, 2014)
  • K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MA (May 23, 2013)