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

FDA 510(k)

Sterile Dilator

K-Number: K192195 · 2019-09-26

ApplicantGalt Medical Corp.
Decision Date2019-09-26
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sterile Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Galt Medical Corp.. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K192195. 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 Sterile Dilator?

Sterile Dilator is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Galt Medical Corp.. The 510(k) number is K192195.

When did Sterile Dilator receive FDA 510(k) clearance?

Sterile Dilator received FDA 510(k) clearance on 2019-09-26, under 510(k) number K192195.

Who is the listed applicant for Sterile Dilator?

The FDA 510(k) record lists Galt Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Dilator?

The FDA product code for Sterile Dilator is DRE.

Other records listing Galt Medical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182660GaltTWSK173287Elite HV RadialK172487Coaxial Dilator Set (Micro-Introducer)K153533Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

Related Devices (Code: DRE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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.

↑