FDA 510(k)

COOK PRESSURE MONITORING CATHETER

K-Number: K002254 · 2001-03-16

Decision Date2001-03-16

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

COOK PRESSURE MONITORING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2001-03-16 under 510(k) number K002254. 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 COOK PRESSURE MONITORING CATHETER?

COOK PRESSURE MONITORING CATHETER is a medical device that received FDA 510(k) clearance on 2001-03-16. The listed applicant is Cook, Inc.. The 510(k) number is K002254.

When did COOK PRESSURE MONITORING CATHETER receive FDA 510(k) clearance?

COOK PRESSURE MONITORING CATHETER received FDA 510(k) clearance on 2001-03-16, under 510(k) number K002254.

Who is the listed applicant for COOK PRESSURE MONITORING CATHETER?

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

What is the FDA product code for COOK PRESSURE MONITORING CATHETER?

The FDA product code for COOK PRESSURE MONITORING CATHETER is DQO.

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Related Devices (Code: DQO)

K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular K252702Bioptimal 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 Vascular K250751DualView CatheterTerumo Corporation K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC K242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.