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FDA 510(k)

BIPOLAR ENDOCARDIAL LEAD 406L

K-Number: K841227 · 1984-11-27

ApplicantSiemens Elema AB
Decision Date1984-11-27
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIPOLAR ENDOCARDIAL LEAD 406L 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 1984-11-27 under 510(k) number K841227. The device is classified under product code DTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIPOLAR ENDOCARDIAL LEAD 406L?

BIPOLAR ENDOCARDIAL LEAD 406L is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Siemens Elema AB. The 510(k) number is K841227.

When did BIPOLAR ENDOCARDIAL LEAD 406L receive FDA 510(k) clearance?

BIPOLAR ENDOCARDIAL LEAD 406L received FDA 510(k) clearance on 1984-11-27, under 510(k) number K841227.

Who is the listed applicant for BIPOLAR ENDOCARDIAL LEAD 406L?

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 BIPOLAR ENDOCARDIAL LEAD 406L?

The FDA product code for BIPOLAR ENDOCARDIAL LEAD 406L is DTD.

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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: DTD)

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.

K1320086981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAPMedtronic, Inc.K041574CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020Guidant CorporationK031164PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLVOscor, Inc.K024156PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAROscor, Inc.K010787PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONSOscor, Inc.K003454A1-CS-SB Y-ADAPTER, MODEL 124 871Biotronik, 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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