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510(k) K192283

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator by Medron, LLC — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2020
Date Received
August 22, 2019
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 Medron, LLC

  • K971897 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) (October 21, 1997)
  • K940775 — INJECTION CAP (June 15, 1994)

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