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FDA 510(k)

MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS

K-Number: K030589 · 2003-05-21

ApplicantNuMED, Inc.
Decision Date2003-05-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 2003-05-21 under 510(k) number K030589. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS?

MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS is a medical device that received FDA 510(k) clearance on 2003-05-21. The listed applicant is NuMED, Inc.. The 510(k) number is K030589.

When did MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS receive FDA 510(k) clearance?

MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS received FDA 510(k) clearance on 2003-05-21, under 510(k) number K030589.

Who is the listed applicant for MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS?

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 MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS?

The FDA product code for MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS is DQY.

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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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