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510(k) K082905

MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC by Medrad, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2009
Date Received
September 30, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

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  • K111182 — ANGIOJET SOLENT OMNI THROMBECTOMY SET (May 24, 2011)
  • K100798 — MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRAT (June 23, 2010)

Other clearances for product code DXT

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  • K241109 — Single-use Sterile High-pressure Angiographic Syringes and Accessories (August 22, 2024)
  • K230668 — Disposable High-pressure Extension Lines (June 14, 2024)
  • K232388 — High Pressure Tubing (November 21, 2023)
  • K211564 — Sterile High-pressure Angiographic Syringes for Single-use (October 19, 2021)
  • K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System (December 17, 2020)