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FDA 510(k)

PERCUTANEOUS CATHETER INTRODUCER

K-Number: K800580 · 1980-04-02

ApplicantAlva Medical, Inc.
Decision Date1980-04-02
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS CATHETER INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Alva Medical, Inc.. It received FDA 510(k) clearance on 1980-04-02 under 510(k) number K800580. 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 PERCUTANEOUS CATHETER INTRODUCER?

PERCUTANEOUS CATHETER INTRODUCER is a medical device that received FDA 510(k) clearance on 1980-04-02. The listed applicant is Alva Medical, Inc.. The 510(k) number is K800580.

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

PERCUTANEOUS CATHETER INTRODUCER received FDA 510(k) clearance on 1980-04-02, under 510(k) number K800580.

Who is the listed applicant for PERCUTANEOUS CATHETER INTRODUCER?

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

What is the FDA product code for PERCUTANEOUS CATHETER INTRODUCER?

The FDA product code for PERCUTANEOUS CATHETER INTRODUCER 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 Alva Medical, Inc. 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.

K801113DILATOR, VESSEL, FOR PERC. CATHETER.

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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