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: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET

K-Number: K082670 · 2008-12-04

ApplicantMedtronic, Inc.
Decision Date2008-12-04
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2008-12-04 under 510(k) number K082670. 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: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET?

MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET is a medical device that received FDA 510(k) clearance on 2008-12-04. The listed applicant is Medtronic, Inc.. The 510(k) number is K082670.

When did MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET receive FDA 510(k) clearance?

MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET received FDA 510(k) clearance on 2008-12-04, under 510(k) number K082670.

Who is the listed applicant for MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET?

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

What is the FDA product code for MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET?

The FDA product code for MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET 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 Medtronic, 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.

K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemK262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)K262005Affera Integrated Mapping SystemK261335VitalFlow Set with Balance™ BiosurfaceK261866Concerto Versa™ Detachable CoilK260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae

View all 182 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.

↑