Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Arterial Pressure Monitoring Set/Tray

K-Number: K180792 · 2018-11-30

ApplicantCook Incorporated
Decision Date2018-11-30
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arterial Pressure Monitoring Set/Tray is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K180792. 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 Arterial Pressure Monitoring Set/Tray?

Arterial Pressure Monitoring Set/Tray is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Cook Incorporated. The 510(k) number is K180792.

When did Arterial Pressure Monitoring Set/Tray receive FDA 510(k) clearance?

Arterial Pressure Monitoring Set/Tray received FDA 510(k) clearance on 2018-11-30, under 510(k) number K180792.

Who is the listed applicant for Arterial Pressure Monitoring Set/Tray?

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

What is the FDA product code for Arterial Pressure Monitoring Set/Tray?

The FDA product code for Arterial Pressure Monitoring Set/Tray is DQO.

Related Clinical Trials

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.

NCT07035756Development of an Arterial Pressure Monitoring Set Fixation ApparatusCOMPLETED

Other records listing Cook Incorporated as applicant

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.

PMA P020018SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTK233177Nest VT Vitrification DeviceK222254Gunther Tulip Vena Cava Filter Retrieval SetK223098Bakri Essential Postpartum BalloonK210734Endovascular Dilator and SetsK203670Extra Large Check-Flo Introducer

View all 147 devices →

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.

↑