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FDA 510(k)

M-Y Sheath

K-Number: K190369 · 2019-04-17

ApplicantRam Medical Innovations, Inc.
Decision Date2019-04-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M-Y Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Ram Medical Innovations, Inc.. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K190369. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M-Y Sheath?

M-Y Sheath is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Ram Medical Innovations, Inc.. The 510(k) number is K190369.

When did M-Y Sheath receive FDA 510(k) clearance?

M-Y Sheath received FDA 510(k) clearance on 2019-04-17, under 510(k) number K190369.

Who is the listed applicant for M-Y Sheath?

The FDA 510(k) record lists Ram Medical Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M-Y Sheath?

The FDA product code for M-Y Sheath is DYB.

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.

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