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FDA 510(k)

TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT

K-Number: K913114 · 1992-01-02

ApplicantGerard Medical Enterprises, Inc.
Decision Date1992-01-02
Product CodeFMF
Advisory CommitteeHO
DecisionUnknown

Device Summary

TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT is the device name listed in this FDA 510(k) record. The listed applicant is Gerard Medical Enterprises, Inc.. It received FDA 510(k) clearance on 1992-01-02 under 510(k) number K913114. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT?

TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT is a medical device that received FDA 510(k) clearance on 1992-01-02. The listed applicant is Gerard Medical Enterprises, Inc.. The 510(k) number is K913114.

When did TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT receive FDA 510(k) clearance?

TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT received FDA 510(k) clearance on 1992-01-02, under 510(k) number K913114.

Who is the listed applicant for TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT?

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

What is the FDA product code for TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT?

The FDA product code for TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT is FMF.

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Other records listing Gerard Medical Enterprises, 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.

K954258TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)K945250TRIMPORTK942623TRIMPORTK922147DUAL PLASTIC VASCULAR ACCESS SYSTEMK912111MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTEK903364GERARD MEDICAL, INC. TRIM-PORT

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Related Devices (Code: FMF)

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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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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