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FDA 510(k)

SUBCLAVIAN LEAD INTRODUCER SYS

K-Number: K843642 · 1984-10-23

ApplicantXanmed Corp.
Decision Date1984-10-23
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SUBCLAVIAN LEAD INTRODUCER SYS is the device name listed in this FDA 510(k) record. The listed applicant is Xanmed Corp.. It received FDA 510(k) clearance on 1984-10-23 under 510(k) number K843642. 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 SUBCLAVIAN LEAD INTRODUCER SYS?

SUBCLAVIAN LEAD INTRODUCER SYS is a medical device that received FDA 510(k) clearance on 1984-10-23. The listed applicant is Xanmed Corp.. The 510(k) number is K843642.

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

SUBCLAVIAN LEAD INTRODUCER SYS received FDA 510(k) clearance on 1984-10-23, under 510(k) number K843642.

Who is the listed applicant for SUBCLAVIAN LEAD INTRODUCER SYS?

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

What is the FDA product code for SUBCLAVIAN LEAD INTRODUCER SYS?

The FDA product code for SUBCLAVIAN LEAD INTRODUCER SYS is DYB.

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Other records listing Xanmed Corp. 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.

K864623OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KITK844595ORTHOPEDIC CUSTOM SURGICAL KITK844596EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KITK844593CARDIOVASCULAR CUSTOM SURGICAL KITK844594NEURO CUSTOM SURGICAL KITK851906SURGICAL EYE PACK

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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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