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510(k) K802326

PRESSURE MONITORING LINES by Stanco Medical, Inc. — Product Code DRI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
September 23, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Line Isolation
Device Class
Class I
Regulation Number
870.2620
Review Panel
CV
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)
  • K802289 — PERICARDIOCENTESIS KIT (November 26, 1980)
  • K802288 — SWAN GANZ CATHETER PLACEMENT KIT (November 20, 1980)
  • K802287 — RIGHT ATRIAL LINE 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)
  • K802260 — VASCULAR CATHETER WIREGUIDES (October 10, 1980)

Other clearances for product code DRI

  • K902493 — CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR (July 6, 1990)
  • K902492 — CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S (July 6, 1990)
  • K822316 — HEART MONITOR BRACELET ALARM (September 21, 1982)