MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator

FDA 510(k) K192283 · Medron, LLC

Substantially Equivalent

510(k) numberK192283

Submission

Device name
MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
Applicant
Medron, LLC
Salt Lake City, UT, US
Received
August 22, 2019
Decision date
May 6, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRE – Dilator, Vessel, For Percutaneous Catheterization
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1310
Specialty
Cardiovascular

Other 510(k)s with product code DRE

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K261310FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional Merit Medical Systems, Inc.07/27/2026SE
K253616ProtekDilate Vascular Access KitDRE · Special Sorin Group Italia S.R.L.12/19/2025SE
K251325VersaCross Connect™ Transseptal DilatorDRE · Special Baylis Medical Company, Inc.05/29/2025SE
K242229Micro Ace Gold Advanced Micro Access SystemDRE · Traditional Merit Medical Systems, Inc.01/15/2025SE
K241720VersaCross Connect™ Transseptal DilatorDRE · Special Baylis Medical Company, Inc.07/12/2024SE
K233647VersaCross Connect™ Transseptal DilatorDRE · Special Baylis Medical Company, Inc.12/14/2023SE
K232609Micro Ace™ Advanced Micro Access SystemDRE · Special Merit Medical Systems, Inc.09/27/2023SE
K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special Spectranetics, Inc.12/15/2022SE
K212784TightRail Guardian Motorized Dilator SheathDRE · Traditional Spectranetics, Inc.08/24/2022SE
K211679Xtractor deviceDRE · Traditional Xcardia Innovation , Ltd.02/17/2022SE

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Questions and answers

When was MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator cleared by the FDA?

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator (K192283) received a 510(k) decision of Substantially Equivalent on May 6, 2020, 258 days after the submission was received.

What is the product code of K192283?

The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.