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FDA 510(k)

BIOTRONIK'S PS-ENDOCARDIAL LEADS

K-Number: K896824 · 1990-08-08

ApplicantBiotronik, GmbH & Co.
Decision Date1990-08-08
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOTRONIK'S PS-ENDOCARDIAL LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, GmbH & Co.. It received FDA 510(k) clearance on 1990-08-08 under 510(k) number K896824. 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'S PS-ENDOCARDIAL LEADS?

BIOTRONIK'S PS-ENDOCARDIAL LEADS is a medical device that received FDA 510(k) clearance on 1990-08-08. The listed applicant is Biotronik, GmbH & Co.. The 510(k) number is K896824.

When did BIOTRONIK'S PS-ENDOCARDIAL LEADS receive FDA 510(k) clearance?

BIOTRONIK'S PS-ENDOCARDIAL LEADS received FDA 510(k) clearance on 1990-08-08, under 510(k) number K896824.

Who is the listed applicant for BIOTRONIK'S PS-ENDOCARDIAL LEADS?

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

What is the FDA product code for BIOTRONIK'S PS-ENDOCARDIAL LEADS?

The FDA product code for BIOTRONIK'S PS-ENDOCARDIAL LEADS is DTB.

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Other records listing Biotronik, GmbH & Co. as applicant

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.

K000763PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051K923406BIOSCOPEK923026PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKERK922742HPM 40 HEART PACEMAKER MONITORK914109PIKOS 01 & PIKOS E 01K910609PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP

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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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