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FDA 510(k)

Renal Access Cobra Catheter, Kumpe Access Catheter

K-Number: K171600 · 2018-02-16

ApplicantCook Incorporated
Decision Date2018-02-16
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Renal Access Cobra Catheter, Kumpe Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K171600. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Renal Access Cobra Catheter, Kumpe Access Catheter?

Renal Access Cobra Catheter, Kumpe Access Catheter is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Cook Incorporated. The 510(k) number is K171600.

When did Renal Access Cobra Catheter, Kumpe Access Catheter receive FDA 510(k) clearance?

Renal Access Cobra Catheter, Kumpe Access Catheter received FDA 510(k) clearance on 2018-02-16, under 510(k) number K171600.

Who is the listed applicant for Renal Access Cobra Catheter, Kumpe Access Catheter?

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

What is the FDA product code for Renal Access Cobra Catheter, Kumpe Access Catheter?

The FDA product code for Renal Access Cobra Catheter, Kumpe Access Catheter is KOD.

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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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