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)

MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101

K-Number: K063638 · 2007-05-11

ApplicantSt Jude Medical
Decision Date2007-05-11
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2007-05-11 under 510(k) number K063638. 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 MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101?

MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 is a medical device that received FDA 510(k) clearance on 2007-05-11. The listed applicant is St Jude Medical. The 510(k) number is K063638.

When did MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 receive FDA 510(k) clearance?

MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 received FDA 510(k) clearance on 2007-05-11, under 510(k) number K063638.

Who is the listed applicant for MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101?

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

What is the FDA product code for MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101?

The FDA product code for MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 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 St Jude Medical 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.

K181382GuardianTM Burr Hole Cover SystemK172396EnSite Velocity Cardiac Mapping System v5.2K173232myMerlin(TM) Mobile Application Model APP1001K160210EnSite Precision Cardiac Mapping System v2.0K162643MediGuide Technology SystemK160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D

View all 95 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, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK262240SSPC NXT 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.

↑