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FDA 510(k)

PROGUIDE CHRONIC DIALYSIS CATHETER

K-Number: K090148 · 2009-04-13

ApplicantMerit Medical Systems, Inc.
Decision Date2009-04-13
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PROGUIDE CHRONIC DIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2009-04-13 under 510(k) number K090148. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROGUIDE CHRONIC DIALYSIS CATHETER?

PROGUIDE CHRONIC DIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 2009-04-13. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K090148.

When did PROGUIDE CHRONIC DIALYSIS CATHETER receive FDA 510(k) clearance?

PROGUIDE CHRONIC DIALYSIS CATHETER received FDA 510(k) clearance on 2009-04-13, under 510(k) number K090148.

Who is the listed applicant for PROGUIDE CHRONIC DIALYSIS CATHETER?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROGUIDE CHRONIC DIALYSIS CATHETER?

The FDA product code for PROGUIDE CHRONIC DIALYSIS CATHETER is MSD.

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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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