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)

ONSET ACCESS CATHETER SYSTEM

K-Number: K112629 · 2011-10-11

ApplicantOnset Medical Corporation
Decision Date2011-10-11
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ONSET ACCESS CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Onset Medical Corporation. It received FDA 510(k) clearance on 2011-10-11 under 510(k) number K112629. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONSET ACCESS CATHETER SYSTEM?

ONSET ACCESS CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-11. The listed applicant is Onset Medical Corporation. The 510(k) number is K112629.

When did ONSET ACCESS CATHETER SYSTEM receive FDA 510(k) clearance?

ONSET ACCESS CATHETER SYSTEM received FDA 510(k) clearance on 2011-10-11, under 510(k) number K112629.

Who is the listed applicant for ONSET ACCESS CATHETER SYSTEM?

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

What is the FDA product code for ONSET ACCESS CATHETER SYSTEM?

The FDA product code for ONSET ACCESS CATHETER SYSTEM is DQY.

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 Onset Medical Corporation 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.

K152498SoloPath Re-Collapsible Access SystemK121404SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEMK100819THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCERK092014SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCERK062852BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870K061009PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS

View all 8 devices →

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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.

↑