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FDA 510(k)

MERIT IMPRESS DIAGNOSTIC CATHETER

K-Number: K053171 · 2006-01-19

ApplicantMerit Medical Systems, Inc.
Decision Date2006-01-19
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MERIT IMPRESS DIAGNOSTIC 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 2006-01-19 under 510(k) number K053171. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERIT IMPRESS DIAGNOSTIC CATHETER?

MERIT IMPRESS DIAGNOSTIC CATHETER is a medical device that received FDA 510(k) clearance on 2006-01-19. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K053171.

When did MERIT IMPRESS DIAGNOSTIC CATHETER receive FDA 510(k) clearance?

MERIT IMPRESS DIAGNOSTIC CATHETER received FDA 510(k) clearance on 2006-01-19, under 510(k) number K053171.

Who is the listed applicant for MERIT IMPRESS DIAGNOSTIC 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 MERIT IMPRESS DIAGNOSTIC CATHETER?

The FDA product code for MERIT IMPRESS DIAGNOSTIC CATHETER is DQO.

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Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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