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FDA 510(k)

ND NABIL DIB INFUSION CATHETER

K-Number: K130569 · 2013-11-15

ApplicantTranslational Research Institute
Decision Date2013-11-15
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ND NABIL DIB INFUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Translational Research Institute. It received FDA 510(k) clearance on 2013-11-15 under 510(k) number K130569. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ND NABIL DIB INFUSION CATHETER?

ND NABIL DIB INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 2013-11-15. The listed applicant is Translational Research Institute. The 510(k) number is K130569.

When did ND NABIL DIB INFUSION CATHETER receive FDA 510(k) clearance?

ND NABIL DIB INFUSION CATHETER received FDA 510(k) clearance on 2013-11-15, under 510(k) number K130569.

Who is the listed applicant for ND NABIL DIB INFUSION CATHETER?

The FDA 510(k) record lists Translational Research Institute as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ND NABIL DIB INFUSION CATHETER?

The FDA product code for ND NABIL DIB INFUSION CATHETER is KRA.

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Related Devices (Code: KRA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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