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)

SYRINGE SET, 3-WAY THERMODILUTIN

K-Number: K760402 · 1976-08-23

ApplicantOmp Laboratories, Inc.
Decision Date1976-08-23
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYRINGE SET, 3-WAY THERMODILUTIN is the device name listed in this FDA 510(k) record. The listed applicant is Omp Laboratories, Inc.. It received FDA 510(k) clearance on 1976-08-23 under 510(k) number K760402. 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 SYRINGE SET, 3-WAY THERMODILUTIN?

SYRINGE SET, 3-WAY THERMODILUTIN is a medical device that received FDA 510(k) clearance on 1976-08-23. The listed applicant is Omp Laboratories, Inc.. The 510(k) number is K760402.

When did SYRINGE SET, 3-WAY THERMODILUTIN receive FDA 510(k) clearance?

SYRINGE SET, 3-WAY THERMODILUTIN received FDA 510(k) clearance on 1976-08-23, under 510(k) number K760402.

Who is the listed applicant for SYRINGE SET, 3-WAY THERMODILUTIN?

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

What is the FDA product code for SYRINGE SET, 3-WAY THERMODILUTIN?

The FDA product code for SYRINGE SET, 3-WAY THERMODILUTIN 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Omp Laboratories, Inc. 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.

K780703CUFF PACER

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.

↑