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FDA 510(k)

SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854

K-Number: K991169 · 1999-07-01

ApplicantBiotronik, Inc.
Decision Date1999-07-01
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 1999-07-01 under 510(k) number K991169. 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 SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854?

SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 is a medical device that received FDA 510(k) clearance on 1999-07-01. The listed applicant is Biotronik, Inc.. The 510(k) number is K991169.

When did SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 receive FDA 510(k) clearance?

SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 received FDA 510(k) clearance on 1999-07-01, under 510(k) number K991169.

Who is the listed applicant for SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854?

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 SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854?

The FDA product code for SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 is DTB.

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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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