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FDA 510(k)

PROGREAT

K-Number: K033583 · 2003-12-12

ApplicantTerumo Medical Corp.
Decision Date2003-12-12
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROGREAT is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 2003-12-12 under 510(k) number K033583. 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 PROGREAT?

PROGREAT is a medical device that received FDA 510(k) clearance on 2003-12-12. The listed applicant is Terumo Medical Corp.. The 510(k) number is K033583.

When did PROGREAT receive FDA 510(k) clearance?

PROGREAT received FDA 510(k) clearance on 2003-12-12, under 510(k) number K033583.

Who is the listed applicant for PROGREAT?

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

What is the FDA product code for PROGREAT?

The FDA product code for PROGREAT is DQO.

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Other records listing Terumo Medical Corp. as applicant

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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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