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510(k) K802289

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

K802289 is an FDA 510(k) premarket notification submitted by Stanco Medical, Inc. for the device "PERICARDIOCENTESIS KIT". The FDA issued a decision of Substantially Equivalent on November 26, 1980. The device falls under product code DOR (Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.), a Class II device regulated under 21 CFR 862.3320. Stanco Medical, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K810643 — UNIVERSAL PACING ELECTRODE KIT (April 8, 1981)
  • K810642 — ATRIAL-VENTRICULAR 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)
  • K802260 — VASCULAR CATHETER WIREGUIDES (October 10, 1980)
  • K802326 — PRESSURE MONITORING LINES (October 10, 1980)
  • K802327 — SHEATH DILATOR SET (October 10, 1980)
  • K802328 — DISP. TOUGY-BORST TYPE ADAPTOR W/PORT (October 10, 1980)

FDA data resources