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FDA 510(k)

MENTOR PATHWAY INTRODUCER/DILATOR

K-Number: K981527 · 1998-07-09

ApplicantMentor Corp.
Decision Date1998-07-09
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MENTOR PATHWAY INTRODUCER/DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1998-07-09 under 510(k) number K981527. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR PATHWAY INTRODUCER/DILATOR?

MENTOR PATHWAY INTRODUCER/DILATOR is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Mentor Corp.. The 510(k) number is K981527.

When did MENTOR PATHWAY INTRODUCER/DILATOR receive FDA 510(k) clearance?

MENTOR PATHWAY INTRODUCER/DILATOR received FDA 510(k) clearance on 1998-07-09, under 510(k) number K981527.

Who is the listed applicant for MENTOR PATHWAY INTRODUCER/DILATOR?

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 PATHWAY INTRODUCER/DILATOR?

The FDA product code for MENTOR PATHWAY INTRODUCER/DILATOR is QPB.

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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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