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FDA 510(k)

BIOTRONIK ENDOCARDIAL PACING LEADS

K-Number: K061212 · 2006-07-10

ApplicantBiotronik, Inc.
Decision Date2006-07-10
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOTRONIK ENDOCARDIAL PACING LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2006-07-10 under 510(k) number K061212. 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 BIOTRONIK ENDOCARDIAL PACING LEADS?

BIOTRONIK ENDOCARDIAL PACING LEADS is a medical device that received FDA 510(k) clearance on 2006-07-10. The listed applicant is Biotronik, Inc.. The 510(k) number is K061212.

When did BIOTRONIK ENDOCARDIAL PACING LEADS receive FDA 510(k) clearance?

BIOTRONIK ENDOCARDIAL PACING LEADS received FDA 510(k) clearance on 2006-07-10, under 510(k) number K061212.

Who is the listed applicant for BIOTRONIK ENDOCARDIAL PACING LEADS?

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

What is the FDA product code for BIOTRONIK ENDOCARDIAL PACING LEADS?

The FDA product code for BIOTRONIK ENDOCARDIAL PACING LEADS is DTB.

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Other records listing Biotronik, 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.

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.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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