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FDA 510(k)

LEADS, IMPLANTABLE CARDIAC PACEMAKERS

K-Number: K782018 · 1979-06-04

ApplicantOscor, Inc.
Decision Date1979-06-04
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEADS, IMPLANTABLE CARDIAC PACEMAKERS is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 1979-06-04 under 510(k) number K782018. 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 LEADS, IMPLANTABLE CARDIAC PACEMAKERS?

LEADS, IMPLANTABLE CARDIAC PACEMAKERS is a medical device that received FDA 510(k) clearance on 1979-06-04. The listed applicant is Oscor, Inc.. The 510(k) number is K782018.

When did LEADS, IMPLANTABLE CARDIAC PACEMAKERS receive FDA 510(k) clearance?

LEADS, IMPLANTABLE CARDIAC PACEMAKERS received FDA 510(k) clearance on 1979-06-04, under 510(k) number K782018.

Who is the listed applicant for LEADS, IMPLANTABLE CARDIAC PACEMAKERS?

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 LEADS, IMPLANTABLE CARDIAC PACEMAKERS?

The FDA product code for LEADS, IMPLANTABLE CARDIAC PACEMAKERS is DTB.

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Other records listing Oscor, Inc. as applicant

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K210627Breezeway IIK130104GUIDEWIRE, PURSUER SERIESK122958DELIVERY SHEATH, MODEL ADELANTE BREEZEWAYK122960STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINOK122084INTRODUCER SET, MODEL ADELANTE-S SERIESK120459STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO

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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.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, 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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