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510(k) K802289

PERICARDIOCENTESIS KIT by Stanco Medical, Inc. — Product Code DOR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1980
Date Received
September 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
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)
  • 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)
  • K802326 — PRESSURE MONITORING LINES (October 10, 1980)
  • K802260 — VASCULAR CATHETER WIREGUIDES (October 10, 1980)
  • K802327 — SHEATH DILATOR SET (October 10, 1980)
  • K802328 — DISP. TOUGY-BORST TYPE ADAPTOR W/PORT (October 10, 1980)