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FDA 510(k)

BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60

K-Number: K820767 · 1982-04-09

ApplicantSiemens Elema AB
Decision Date1982-04-09
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Elema AB. It received FDA 510(k) clearance on 1982-04-09 under 510(k) number K820767. 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 BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60?

BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60 is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is Siemens Elema AB. The 510(k) number is K820767.

When did BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60 receive FDA 510(k) clearance?

BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60 received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820767.

Who is the listed applicant for BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60?

The FDA 510(k) record lists Siemens Elema AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60?

The FDA product code for BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60 is DTB.

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Other records listing Siemens Elema AB 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.

K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81EK010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392EK010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407EK002137CATHCOR DESKTOPK001315MODIFICATION TO KION ANESTHESIA SYSTEMK970839SERVO VENTILATOR 300A

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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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