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FDA 510(k)

MERIT CUSTOM KIT

K-Number: K913682 · 1991-11-15

ApplicantMerit Medical Systems, Inc.
Decision Date1991-11-15
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MERIT CUSTOM KIT 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 1991-11-15 under 510(k) number K913682. 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 CUSTOM KIT?

MERIT CUSTOM KIT is a medical device that received FDA 510(k) clearance on 1991-11-15. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K913682.

When did MERIT CUSTOM KIT receive FDA 510(k) clearance?

MERIT CUSTOM KIT received FDA 510(k) clearance on 1991-11-15, under 510(k) number K913682.

Who is the listed applicant for MERIT CUSTOM KIT?

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 CUSTOM KIT?

The FDA product code for MERIT CUSTOM KIT is DQO.

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Related Devices (Code: DQO)

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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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