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FDA 510(k)

INTRACOIL PERIPHERAL STENT

K-Number: K990221 · 1999-06-02

ApplicantIntratherapeutics, Inc.
Decision Date1999-06-02
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTRACOIL PERIPHERAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Intratherapeutics, Inc.. It received FDA 510(k) clearance on 1999-06-02 under 510(k) number K990221. The device is classified under product code JCT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRACOIL PERIPHERAL STENT?

INTRACOIL PERIPHERAL STENT is a medical device that received FDA 510(k) clearance on 1999-06-02. The listed applicant is Intratherapeutics, Inc.. The 510(k) number is K990221.

When did INTRACOIL PERIPHERAL STENT receive FDA 510(k) clearance?

INTRACOIL PERIPHERAL STENT received FDA 510(k) clearance on 1999-06-02, under 510(k) number K990221.

Who is the listed applicant for INTRACOIL PERIPHERAL STENT?

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

What is the FDA product code for INTRACOIL PERIPHERAL STENT?

The FDA product code for INTRACOIL PERIPHERAL STENT is JCT.

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Other records listing Intratherapeutics, 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.

K011184INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESISK003997INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESISK003040INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGYK003450INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESISK001648INTRASTENT DOUBLESTRUT PARAMOUNTK001257INTRACOIL STENT

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Related Devices (Code: JCT)

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.

K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific CorporationK220424Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.K212403Tracheal Stent System (Y-Shaped)Micro-Tech (Nanjing) Co., Ltd.K202204Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc.

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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