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510(k) K802327

SHEATH DILATOR SET by Stanco Medical, Inc. — Product Code DRE

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
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
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)
  • 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)
  • K802328 — DISP. TOUGY-BORST TYPE ADAPTOR W/PORT (October 10, 1980)

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  • K251325 — VersaCross Connect™ Transseptal Dilator (May 29, 2025)
  • K242229 — Micro Ace Gold Advanced Micro Access System (January 15, 2025)
  • K241720 — VersaCross Connect™ Transseptal Dilator (July 12, 2024)
  • K233647 — VersaCross Connect™ Transseptal Dilator (December 14, 2023)
  • K232609 — Micro Ace™ Advanced Micro Access System (September 27, 2023)
  • K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guard (December 15, 2022)
  • K212784 — TightRail Guardian Motorized Dilator Sheath (August 24, 2022)
  • K211679 — Xtractor device (February 17, 2022)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)