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FDA 510(k)

TYSHAK PERIPHERAL BALLOON DILATION CATHETER

K-Number: K931009 · 1993-12-21

ApplicantNuMED, Inc.
Decision Date1993-12-21
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TYSHAK PERIPHERAL BALLOON DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 1993-12-21 under 510(k) number K931009. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYSHAK PERIPHERAL BALLOON DILATION CATHETER?

TYSHAK PERIPHERAL BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 1993-12-21. The listed applicant is NuMED, Inc.. The 510(k) number is K931009.

When did TYSHAK PERIPHERAL BALLOON DILATION CATHETER receive FDA 510(k) clearance?

TYSHAK PERIPHERAL BALLOON DILATION CATHETER received FDA 510(k) clearance on 1993-12-21, under 510(k) number K931009.

Who is the listed applicant for TYSHAK PERIPHERAL BALLOON DILATION CATHETER?

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

What is the FDA product code for TYSHAK PERIPHERAL BALLOON DILATION CATHETER?

The FDA product code for TYSHAK PERIPHERAL BALLOON DILATION CATHETER is LIT.

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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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