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510(k) K802326

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

K802326 is an FDA 510(k) premarket notification submitted by Stanco Medical, Inc. for the device "PRESSURE MONITORING LINES". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code DRI (Monitor, Line Isolation), a Class I device regulated under 21 CFR 870.2620. Stanco Medical, Inc. has at least 10 other 510(k) clearances on record.

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.

  • 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)
  • K802260 — VASCULAR CATHETER WIREGUIDES (October 10, 1980)
  • K802328 — DISP. TOUGY-BORST TYPE ADAPTOR W/PORT (October 10, 1980)
  • K802327 — SHEATH DILATOR SET (October 10, 1980)

Other clearances for product code DRI

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

FDA data resources