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)

MODIFIED CONCENTRIC MICROCATHETER

K-Number: K131437 · 2013-10-11

ApplicantConcentric Medical, Inc.
Decision Date2013-10-11
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED CONCENTRIC MICROCATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Concentric Medical, Inc.. It received FDA 510(k) clearance on 2013-10-11 under 510(k) number K131437. 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 MODIFIED CONCENTRIC MICROCATHETER?

MODIFIED CONCENTRIC MICROCATHETER is a medical device that received FDA 510(k) clearance on 2013-10-11. The listed applicant is Concentric Medical, Inc.. The 510(k) number is K131437.

When did MODIFIED CONCENTRIC MICROCATHETER receive FDA 510(k) clearance?

MODIFIED CONCENTRIC MICROCATHETER received FDA 510(k) clearance on 2013-10-11, under 510(k) number K131437.

Who is the listed applicant for MODIFIED CONCENTRIC MICROCATHETER?

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

What is the FDA product code for MODIFIED CONCENTRIC MICROCATHETER?

The FDA product code for MODIFIED CONCENTRIC MICROCATHETER 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 Concentric Medical, 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.

K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)K131492MODIFIED FLOWGATE BALLOON GUIDE CATHETERK122581MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254K122478MODIFIED TREVO RETRIEVERK120961TREVO RETRIEVERK112404CONCENTRIC BALLOON GUIDE CATHETER

View all 39 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.

↑