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FDA 510(k)

PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES

K-Number: K003072 · 2001-01-09

ApplicantBiotronik, Inc.
Decision Date2001-01-09
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2001-01-09 under 510(k) number K003072. 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 PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES?

PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES is a medical device that received FDA 510(k) clearance on 2001-01-09. The listed applicant is Biotronik, Inc.. The 510(k) number is K003072.

When did PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES receive FDA 510(k) clearance?

PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES received FDA 510(k) clearance on 2001-01-09, under 510(k) number K003072.

Who is the listed applicant for PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES?

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 PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES?

The FDA product code for PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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