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FDA 510(k)

MODEL 5071 MYOCARDIAL PACING LEAD

K-Number: K031274 · 2003-05-22

ApplicantMedtronic Vascular
Decision Date2003-05-22
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MODEL 5071 MYOCARDIAL PACING LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2003-05-22 under 510(k) number K031274. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the MODEL 5071 MYOCARDIAL PACING LEAD?

MODEL 5071 MYOCARDIAL PACING LEAD is a medical device that received FDA 510(k) clearance on 2003-05-22. The listed applicant is Medtronic Vascular. The 510(k) number is K031274.

When did MODEL 5071 MYOCARDIAL PACING LEAD receive FDA 510(k) clearance?

MODEL 5071 MYOCARDIAL PACING LEAD received FDA 510(k) clearance on 2003-05-22, under 510(k) number K031274.

Who is the listed applicant for MODEL 5071 MYOCARDIAL PACING LEAD?

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

What is the FDA product code for MODEL 5071 MYOCARDIAL PACING LEAD?

The FDA product code for MODEL 5071 MYOCARDIAL PACING LEAD is DTB.

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Other records listing Medtronic Vascular as applicant

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Related Devices (Code: DTB)

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.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.K024053PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJBOscor, 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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