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FDA 510(k)

MODEL 4951M MYOCARDIAL UNIPOLAR LEAD

K-Number: K031210 · 2003-05-16

ApplicantMetronic, Inc.
Decision Date2003-05-16
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 4951M MYOCARDIAL UNIPOLAR LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Metronic, Inc.. It received FDA 510(k) clearance on 2003-05-16 under 510(k) number K031210. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 4951M MYOCARDIAL UNIPOLAR LEAD?

MODEL 4951M MYOCARDIAL UNIPOLAR LEAD is a medical device that received FDA 510(k) clearance on 2003-05-16. The listed applicant is Metronic, Inc.. The 510(k) number is K031210.

When did MODEL 4951M MYOCARDIAL UNIPOLAR LEAD receive FDA 510(k) clearance?

MODEL 4951M MYOCARDIAL UNIPOLAR LEAD received FDA 510(k) clearance on 2003-05-16, under 510(k) number K031210.

Who is the listed applicant for MODEL 4951M MYOCARDIAL UNIPOLAR LEAD?

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

What is the FDA product code for MODEL 4951M MYOCARDIAL UNIPOLAR LEAD?

The FDA product code for MODEL 4951M MYOCARDIAL UNIPOLAR LEAD is DTB.

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.

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Other records listing Metronic, 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.

K911827MODEL 5866-9M & MODEL 6981MK874884MEDTRONIC(R) ORTHOFLEX(TM)K832505IMAGE PROCESSING SYS A3

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.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK023205ELOX 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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