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FDA 510(k)

INNER-LOCK INTRODUCER SHEATH

K-Number: K051468 · 2005-08-04

ApplicantRex Medical
Decision Date2005-08-04
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INNER-LOCK 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 2005-08-04 under 510(k) number K051468. 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 INNER-LOCK INTRODUCER SHEATH?

INNER-LOCK INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 2005-08-04. The listed applicant is Rex Medical. The 510(k) number is K051468.

When did INNER-LOCK INTRODUCER SHEATH receive FDA 510(k) clearance?

INNER-LOCK INTRODUCER SHEATH received FDA 510(k) clearance on 2005-08-04, under 510(k) number K051468.

Who is the listed applicant for INNER-LOCK 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 INNER-LOCK INTRODUCER SHEATH?

The FDA product code for INNER-LOCK 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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