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FDA 510(k)

NUMED Z-5 ATRIOSEPTOSTOMY CATHETER

K-Number: K001804 · 2000-07-12

ApplicantNuMED, Inc.
Decision Date2000-07-12
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NUMED Z-5 ATRIOSEPTOSTOMY 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 2000-07-12 under 510(k) number K001804. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUMED Z-5 ATRIOSEPTOSTOMY CATHETER?

NUMED Z-5 ATRIOSEPTOSTOMY CATHETER is a medical device that received FDA 510(k) clearance on 2000-07-12. The listed applicant is NuMED, Inc.. The 510(k) number is K001804.

When did NUMED Z-5 ATRIOSEPTOSTOMY CATHETER receive FDA 510(k) clearance?

NUMED Z-5 ATRIOSEPTOSTOMY CATHETER received FDA 510(k) clearance on 2000-07-12, under 510(k) number K001804.

Who is the listed applicant for NUMED Z-5 ATRIOSEPTOSTOMY 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 NUMED Z-5 ATRIOSEPTOSTOMY CATHETER?

The FDA product code for NUMED Z-5 ATRIOSEPTOSTOMY CATHETER is DXF.

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Related Devices (Code: DXF)

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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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