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FDA 510(k)

HEMOSTATIC SIDE-ARM ADAPTER

K-Number: K813578 · 1982-01-18

ApplicantAdvanced Catheter Systems
Decision Date1982-01-18
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEMOSTATIC SIDE-ARM ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Catheter Systems. It received FDA 510(k) clearance on 1982-01-18 under 510(k) number K813578. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSTATIC SIDE-ARM ADAPTER?

HEMOSTATIC SIDE-ARM ADAPTER is a medical device that received FDA 510(k) clearance on 1982-01-18. The listed applicant is Advanced Catheter Systems. The 510(k) number is K813578.

When did HEMOSTATIC SIDE-ARM ADAPTER receive FDA 510(k) clearance?

HEMOSTATIC SIDE-ARM ADAPTER received FDA 510(k) clearance on 1982-01-18, under 510(k) number K813578.

Who is the listed applicant for HEMOSTATIC SIDE-ARM ADAPTER?

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

What is the FDA product code for HEMOSTATIC SIDE-ARM ADAPTER?

The FDA product code for HEMOSTATIC SIDE-ARM ADAPTER is DYG.

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 Advanced Catheter Systems 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.

K813577PRESSURE INDICATOR-REGULATORK813624ADVANCED CATHETER SYSTEMS CORONARY GUIDK813623SIMPSON-ROBERT CORONARY GUIDING CATHETK813622INDEFLATOR

Related Devices (Code: DYG)

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.

K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)Edwards LifesciencesK233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)Edwards LifesciencesK233824Swan-Ganz catheterEdwards Lifesciences, LLCK231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLCK222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLCK193466Swan-Ganz CathetersEdwards Lifesciences, LLC

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.

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