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FDA 510(k)

ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

K-Number: K965106 · 1998-01-27

ApplicantBiotronik, Inc.
Decision Date1998-01-27
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking & PMS

Device Summary

ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 1998-01-27 under 510(k) number K965106. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking & PMS.

Frequently Asked Questions

What is the ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606?

ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 is a medical device that received FDA 510(k) clearance on 1998-01-27. The listed applicant is Biotronik, Inc.. The 510(k) number is K965106.

When did ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 receive FDA 510(k) clearance?

ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 received FDA 510(k) clearance on 1998-01-27, under 510(k) number K965106.

Who is the listed applicant for ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606?

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 ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606?

The FDA product code for ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 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.

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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