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FDA 510(k)

ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM

K-Number: K081803 · 2009-05-13

ApplicantSt Jude Medical
Decision Date2009-05-13
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ST. JUDE MEDICAL EPICARDIAL CATHETER 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 2009-05-13 under 510(k) number K081803. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM?

ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-13. The listed applicant is St Jude Medical. The 510(k) number is K081803.

When did ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM receive FDA 510(k) clearance?

ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM received FDA 510(k) clearance on 2009-05-13, under 510(k) number K081803.

Who is the listed applicant for ST. JUDE MEDICAL EPICARDIAL CATHETER 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 ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM?

The FDA product code for ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM is DRF.

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Related Devices (Code: DRF)

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.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, 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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