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FDA 510(k)

ENDOCARDIAL LEADS 414S & 515S

K-Number: K802816 · 1981-01-16

ApplicantSiemens Elema AB
Decision Date1981-01-16
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENDOCARDIAL LEADS 414S & 515S is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Elema AB. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K802816. 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 ENDOCARDIAL LEADS 414S & 515S?

ENDOCARDIAL LEADS 414S & 515S is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is Siemens Elema AB. The 510(k) number is K802816.

When did ENDOCARDIAL LEADS 414S & 515S receive FDA 510(k) clearance?

ENDOCARDIAL LEADS 414S & 515S received FDA 510(k) clearance on 1981-01-16, under 510(k) number K802816.

Who is the listed applicant for ENDOCARDIAL LEADS 414S & 515S?

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

What is the FDA product code for ENDOCARDIAL LEADS 414S & 515S?

The FDA product code for ENDOCARDIAL LEADS 414S & 515S is DTB.

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Other records listing Siemens Elema AB 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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