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FDA 510(k)

PALMAZ BILIARY STENT

K-Number: K905720 · 1991-02-05

ApplicantJohnson & Johnson Interventional Systems
Decision Date1991-02-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PALMAZ BILIARY STENT is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Interventional Systems. It received FDA 510(k) clearance on 1991-02-05 under 510(k) number K905720. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALMAZ BILIARY STENT?

PALMAZ BILIARY STENT is a medical device that received FDA 510(k) clearance on 1991-02-05. The listed applicant is Johnson & Johnson Interventional Systems. The 510(k) number is K905720.

When did PALMAZ BILIARY STENT receive FDA 510(k) clearance?

PALMAZ BILIARY STENT received FDA 510(k) clearance on 1991-02-05, under 510(k) number K905720.

Who is the listed applicant for PALMAZ BILIARY STENT?

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

What is the FDA product code for PALMAZ BILIARY STENT?

The FDA product code for PALMAZ BILIARY STENT is DQY.

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 Johnson & Johnson Interventional Systems 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.

K911581PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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