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FDA 510(k)

INTRODUCER, PERCUTANEOUS

K-Number: K812143 · 1981-08-18

ApplicantWillson
Decision Date1981-08-18
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRODUCER, PERCUTANEOUS is the device name listed in this FDA 510(k) record. The listed applicant is Willson. It received FDA 510(k) clearance on 1981-08-18 under 510(k) number K812143. 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 INTRODUCER, PERCUTANEOUS?

INTRODUCER, PERCUTANEOUS is a medical device that received FDA 510(k) clearance on 1981-08-18. The listed applicant is Willson. The 510(k) number is K812143.

When did INTRODUCER, PERCUTANEOUS receive FDA 510(k) clearance?

INTRODUCER, PERCUTANEOUS received FDA 510(k) clearance on 1981-08-18, under 510(k) number K812143.

Who is the listed applicant for INTRODUCER, PERCUTANEOUS?

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

What is the FDA product code for INTRODUCER, PERCUTANEOUS?

The FDA product code for INTRODUCER, PERCUTANEOUS 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 Willson 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.

K802576EXTERNAL JUGULAR CVP CATHERIZATION 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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