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FDA 510(k)

S80 IMPLANTABLE CARDIAC PACING LEAD

K-Number: K854963 · 1986-06-24

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1986-06-24
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

S80 IMPLANTABLE CARDIAC PACING LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1986-06-24 under 510(k) number K854963. 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 S80 IMPLANTABLE CARDIAC PACING LEAD?

S80 IMPLANTABLE CARDIAC PACING LEAD is a medical device that received FDA 510(k) clearance on 1986-06-24. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K854963.

When did S80 IMPLANTABLE CARDIAC PACING LEAD receive FDA 510(k) clearance?

S80 IMPLANTABLE CARDIAC PACING LEAD received FDA 510(k) clearance on 1986-06-24, under 510(k) number K854963.

Who is the listed applicant for S80 IMPLANTABLE CARDIAC PACING LEAD?

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

What is the FDA product code for S80 IMPLANTABLE CARDIAC PACING LEAD?

The FDA product code for S80 IMPLANTABLE CARDIAC PACING LEAD is DTB.

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Other records listing Sorin Biomedica, Fiat, USA, 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.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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