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FDA 510(k)

PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU

K-Number: K040569 · 2004-04-07

ApplicantOscor, Inc.
Decision Date2004-04-07
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 2004-04-07 under 510(k) number K040569. 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 PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU?

PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU is a medical device that received FDA 510(k) clearance on 2004-04-07. The listed applicant is Oscor, Inc.. The 510(k) number is K040569.

When did PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU receive FDA 510(k) clearance?

PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU received FDA 510(k) clearance on 2004-04-07, under 510(k) number K040569.

Who is the listed applicant for PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU?

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

What is the FDA product code for PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU?

The FDA product code for PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU is DTB.

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Other records listing Oscor, Inc. 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.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 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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