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FDA 510(k)

MODIFICATION TO SHORT INTRODUCER SHEATH

K-Number: K042399 · 2004-12-17

ApplicantRex Medical, L.P.
Decision Date2004-12-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SHORT INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Rex Medical, L.P.. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K042399. 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 MODIFICATION TO SHORT INTRODUCER SHEATH?

MODIFICATION TO SHORT INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Rex Medical, L.P.. The 510(k) number is K042399.

When did MODIFICATION TO SHORT INTRODUCER SHEATH receive FDA 510(k) clearance?

MODIFICATION TO SHORT INTRODUCER SHEATH received FDA 510(k) clearance on 2004-12-17, under 510(k) number K042399.

Who is the listed applicant for MODIFICATION TO SHORT INTRODUCER SHEATH?

The FDA 510(k) record lists Rex Medical, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO SHORT INTRODUCER SHEATH?

The FDA product code for MODIFICATION TO SHORT INTRODUCER SHEATH is DYB.

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Other records listing Rex Medical, L.P. 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.

K212351Revolution Peripheral Atherectomy SystemK191419Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy GuidewireK173389Rex Medical Aspiration PumpK133243OPTION ELITE VENA CAVA FILTER SYSTEMK060904CLEANER ROTATIONAL THROMBECTOMY SYSTEM

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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