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FDA 510(k)

BI-DIRECTIONAL TUNNELER

K-Number: K991027 · 1999-04-22

ApplicantImpra, Inc.
Decision Date1999-04-22
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BI-DIRECTIONAL TUNNELER is the device name listed in this FDA 510(k) record. The listed applicant is Impra, Inc.. It received FDA 510(k) clearance on 1999-04-22 under 510(k) number K991027. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BI-DIRECTIONAL TUNNELER?

BI-DIRECTIONAL TUNNELER is a medical device that received FDA 510(k) clearance on 1999-04-22. The listed applicant is Impra, Inc.. The 510(k) number is K991027.

When did BI-DIRECTIONAL TUNNELER receive FDA 510(k) clearance?

BI-DIRECTIONAL TUNNELER received FDA 510(k) clearance on 1999-04-22, under 510(k) number K991027.

Who is the listed applicant for BI-DIRECTIONAL TUNNELER?

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

What is the FDA product code for BI-DIRECTIONAL TUNNELER?

The FDA product code for BI-DIRECTIONAL TUNNELER is DSY.

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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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