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FDA 510(k)

TC ENDO PORT

K-Number: K083218 · 2009-03-06

ApplicantTranscardiac Therapeutics, Inc.
Decision Date2009-03-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TC ENDO PORT is the device name listed in this FDA 510(k) record. The listed applicant is Transcardiac Therapeutics, Inc.. It received FDA 510(k) clearance on 2009-03-06 under 510(k) number K083218. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TC ENDO PORT?

TC ENDO PORT is a medical device that received FDA 510(k) clearance on 2009-03-06. The listed applicant is Transcardiac Therapeutics, Inc.. The 510(k) number is K083218.

When did TC ENDO PORT receive FDA 510(k) clearance?

TC ENDO PORT received FDA 510(k) clearance on 2009-03-06, under 510(k) number K083218.

Who is the listed applicant for TC ENDO PORT?

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

What is the FDA product code for TC ENDO PORT?

The FDA product code for TC ENDO PORT is GCJ.

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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