Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K192283 · 2020-05-06

ApplicantMedron, LLC
Decision Date2020-05-06
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator is a medical device manufactured by Medron, LLC. It received FDA 510(k) clearance on 2020-05-06 under approval number K192283. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator?

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator is a medical device that received FDA 510(k) clearance on 2020-05-06. It is manufactured by Medron, LLC. The 510(k) number is K192283.

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

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator received FDA 510(k) clearance on 2020-05-06, under approval number K192283.

What company makes MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator?

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator is manufactured by Medron, LLC.

What is the FDA product code for MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator?

The FDA product code for MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator is DRE.

Related Devices (Code: DRE)

K161336VSI StraitSet micro-introducer kitVascular Solutions, Inc. K150932Sheath IntroducerBioteque Corp. K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. K172487Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp. K162389Medcomp Vessel DilatorMedcomp ( Medical Components) K170616van Andel Dilatation CatheterCook Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑