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FDA 510(k)

Park Blade Septostomy Catheter

K-Number: K182399 · 2019-04-04

ApplicantCook Incorporated
Decision Date2019-04-04
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Park Blade Septostomy 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 2019-04-04 under 510(k) number K182399. 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 Park Blade Septostomy Catheter?

Park Blade Septostomy Catheter is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Cook Incorporated. The 510(k) number is K182399.

When did Park Blade Septostomy Catheter receive FDA 510(k) clearance?

Park Blade Septostomy Catheter received FDA 510(k) clearance on 2019-04-04, under 510(k) number K182399.

Who is the listed applicant for Park Blade Septostomy 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 Park Blade Septostomy Catheter?

The FDA product code for Park Blade Septostomy 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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