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FDA 510(k)

INTROSTAT LEAD INTRODUCER

K-Number: K960200 · 1996-07-02

ApplicantMsi, Inc.
Decision Date1996-07-02
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTROSTAT LEAD INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Msi, Inc.. It received FDA 510(k) clearance on 1996-07-02 under 510(k) number K960200. 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 INTROSTAT LEAD INTRODUCER?

INTROSTAT LEAD INTRODUCER is a medical device that received FDA 510(k) clearance on 1996-07-02. The listed applicant is Msi, Inc.. The 510(k) number is K960200.

When did INTROSTAT LEAD INTRODUCER receive FDA 510(k) clearance?

INTROSTAT LEAD INTRODUCER received FDA 510(k) clearance on 1996-07-02, under 510(k) number K960200.

Who is the listed applicant for INTROSTAT LEAD INTRODUCER?

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

What is the FDA product code for INTROSTAT LEAD INTRODUCER?

The FDA product code for INTROSTAT LEAD INTRODUCER is DYB.

Related Clinical Trials

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.

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Other records listing Msi, Inc. 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.

K944226MSI PROCEDURE KIT

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

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

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