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FDA 510(k)

INTRACOIL SELF-EXPANDING PERIPHERAL STENT

K-Number: K021563 · 2002-05-31

ApplicantSulzer Intratherapeutics, Inc.
Decision Date2002-05-31
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTRACOIL SELF-EXPANDING PERIPHERAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Intratherapeutics, Inc.. It received FDA 510(k) clearance on 2002-05-31 under 510(k) number K021563. 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 SELF-EXPANDING PERIPHERAL STENT?

INTRACOIL SELF-EXPANDING PERIPHERAL STENT is a medical device that received FDA 510(k) clearance on 2002-05-31. The listed applicant is Sulzer Intratherapeutics, Inc.. The 510(k) number is K021563.

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

INTRACOIL SELF-EXPANDING PERIPHERAL STENT received FDA 510(k) clearance on 2002-05-31, under 510(k) number K021563.

Who is the listed applicant for INTRACOIL SELF-EXPANDING PERIPHERAL STENT?

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

What is the FDA product code for INTRACOIL SELF-EXPANDING PERIPHERAL STENT?

The FDA product code for INTRACOIL SELF-EXPANDING PERIPHERAL STENT is JCT.

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Other records listing Sulzer 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.

K023243MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGYK021729MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGYK020528INTRASTENT LD (LARGE DIAMETER) STENTK014136MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGYK011806PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGYK012347PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY

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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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