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510(k) K840022

HEART CATHETERIZATION TRAY SET by Medi-Plast Intl., Inc. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
January 5, 1984
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 Medi-Plast Intl., Inc.

  • K954284 — MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) (February 12, 1996)
  • K873588 — 10CC CONTROL SYRINGE (October 23, 1987)
  • K863402 — MEDI-PLAST DISPOSABLE MANIFOLD (October 22, 1986)
  • K861785 — FLUOROSCOPE BAND BAG (June 13, 1986)
  • K851489 — ARTERIAL-VENOUS COMPRESSION DRESSING (June 11, 1985)
  • K842136 — STERILE PAN SET (July 6, 1984)
  • K840021 — OPERATING ROOM TRAY SET (March 15, 1984)
  • K811234 — I.V. BOTTLE (RIDGID) (June 18, 1981)
  • K811268 — BOTTLE-TO-BOTTLE (June 18, 1981)
  • K811233 — I.V. PLASTIC BAG (June 17, 1981)

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  • K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guard (December 15, 2022)
  • K212784 — TightRail Guardian Motorized Dilator Sheath (August 24, 2022)
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  • K210734 — Endovascular Dilator and Sets (April 6, 2021)