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FDA 510(k)

YP 45/15-BP; YP 53/15-BP; YP 60/15-BP

K-Number: K993139 · 1999-12-17

ApplicantBiotronik, Inc.
Decision Date1999-12-17
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

YP 45/15-BP; YP 53/15-BP; YP 60/15-BP is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 1999-12-17 under 510(k) number K993139. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the YP 45/15-BP; YP 53/15-BP; YP 60/15-BP?

YP 45/15-BP; YP 53/15-BP; YP 60/15-BP is a medical device that received FDA 510(k) clearance on 1999-12-17. The listed applicant is Biotronik, Inc.. The 510(k) number is K993139.

When did YP 45/15-BP; YP 53/15-BP; YP 60/15-BP receive FDA 510(k) clearance?

YP 45/15-BP; YP 53/15-BP; YP 60/15-BP received FDA 510(k) clearance on 1999-12-17, under 510(k) number K993139.

Who is the listed applicant for YP 45/15-BP; YP 53/15-BP; YP 60/15-BP?

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 YP 45/15-BP; YP 53/15-BP; YP 60/15-BP?

The FDA product code for YP 45/15-BP; YP 53/15-BP; YP 60/15-BP is DTB.

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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