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FDA 510(k)

MENTOR INFUSION LINE

K-Number: K912919 · 1991-12-13

ApplicantMentor Corp.
Decision Date1991-12-13
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MENTOR INFUSION LINE is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1991-12-13 under 510(k) number K912919. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR INFUSION LINE?

MENTOR INFUSION LINE is a medical device that received FDA 510(k) clearance on 1991-12-13. The listed applicant is Mentor Corp.. The 510(k) number is K912919.

When did MENTOR INFUSION LINE receive FDA 510(k) clearance?

MENTOR INFUSION LINE received FDA 510(k) clearance on 1991-12-13, under 510(k) number K912919.

Who is the listed applicant for MENTOR INFUSION LINE?

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

What is the FDA product code for MENTOR INFUSION LINE?

The FDA product code for MENTOR INFUSION LINE is KNY.

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Other records listing Mentor Corp. 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

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Related Devices (Code: KNY)

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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