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FDA 510(k)

SHORT INTRODUCER SHEATH

K-Number: K032569 · 2003-09-16

ApplicantRex Medical
Decision Date2003-09-16
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHORT INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Rex Medical. It received FDA 510(k) clearance on 2003-09-16 under 510(k) number K032569. 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 SHORT INTRODUCER SHEATH?

SHORT INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 2003-09-16. The listed applicant is Rex Medical. The 510(k) number is K032569.

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

SHORT INTRODUCER SHEATH received FDA 510(k) clearance on 2003-09-16, under 510(k) number K032569.

Who is the listed applicant for SHORT INTRODUCER SHEATH?

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

What is the FDA product code for SHORT INTRODUCER SHEATH?

The FDA product code for SHORT INTRODUCER SHEATH is DYB.

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Other records listing Rex Medical 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.

K120346CLEANER ROTATIONAL THROMBECTOMY SYSTEMK113103SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICEK102043ULTRASTREAM CHRONIC HEMODIALYSIS CATHETERK091029CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)K081410OPTION VENA CAVA FILTERK07142215.5F HEMO-STREAM HEMODIALYSIS CATHETER SET

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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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