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FDA 510(k)

ATRIUM ICAST COVERED STENT

K-Number: K050814 · 2005-05-06

ApplicantAtrium Medical Corp.
Decision Date2005-05-06
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATRIUM ICAST COVERED STENT is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 2005-05-06 under 510(k) number K050814. 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 ATRIUM ICAST COVERED STENT?

ATRIUM ICAST COVERED STENT is a medical device that received FDA 510(k) clearance on 2005-05-06. The listed applicant is Atrium Medical Corp.. The 510(k) number is K050814.

When did ATRIUM ICAST COVERED STENT receive FDA 510(k) clearance?

ATRIUM ICAST COVERED STENT received FDA 510(k) clearance on 2005-05-06, under 510(k) number K050814.

Who is the listed applicant for ATRIUM ICAST COVERED STENT?

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

What is the FDA product code for ATRIUM ICAST COVERED STENT?

The FDA product code for ATRIUM ICAST COVERED STENT is JCT.

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Other records listing Atrium Medical Corp. as applicant

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K130131EDRAIN CHEST DRAINAGE SYSTEMK122138ATRIUM FLIXENE IFG VASCULAR GRAFTK121070C-QUR RPM MESHK113112CLEARWAY RX NB CATHETERK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912

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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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