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FDA 510(k)

PRELUDE 7F SHORT SHEATH INTRODUCER

K-Number: K122190 · 2012-08-17

ApplicantMerit Medical Systems, Inc.
Decision Date2012-08-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRELUDE 7F SHORT SHEATH INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2012-08-17 under 510(k) number K122190. 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 PRELUDE 7F SHORT SHEATH INTRODUCER?

PRELUDE 7F SHORT SHEATH INTRODUCER is a medical device that received FDA 510(k) clearance on 2012-08-17. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K122190.

When did PRELUDE 7F SHORT SHEATH INTRODUCER receive FDA 510(k) clearance?

PRELUDE 7F SHORT SHEATH INTRODUCER received FDA 510(k) clearance on 2012-08-17, under 510(k) number K122190.

Who is the listed applicant for PRELUDE 7F SHORT SHEATH INTRODUCER?

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

What is the FDA product code for PRELUDE 7F SHORT SHEATH INTRODUCER?

The FDA product code for PRELUDE 7F SHORT SHEATH INTRODUCER is DYB.

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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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