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FDA 510(k)

EPICOR ABLATION SYSTEM

K-Number: K080292 · 2008-07-25

ApplicantSt Jude Medical
Decision Date2008-07-25
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPICOR ABLATION SYSTEM 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 2008-07-25 under 510(k) number K080292. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPICOR ABLATION SYSTEM?

EPICOR ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-25. The listed applicant is St Jude Medical. The 510(k) number is K080292.

When did EPICOR ABLATION SYSTEM receive FDA 510(k) clearance?

EPICOR ABLATION SYSTEM received FDA 510(k) clearance on 2008-07-25, under 510(k) number K080292.

Who is the listed applicant for EPICOR ABLATION SYSTEM?

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 EPICOR ABLATION SYSTEM?

The FDA product code for EPICOR ABLATION SYSTEM is OCL.

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Related Devices (Code: OCL)

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.

K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)AtriCure, Inc.K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.

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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