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FDA 510(k)

IMPLANTABLE HEART LEAD EXTENDER

K-Number: K790468 · 1979-03-19

ApplicantArco Medical Products Co.
Decision Date1979-03-19
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPLANTABLE HEART LEAD EXTENDER is the device name listed in this FDA 510(k) record. The listed applicant is Arco Medical Products Co.. It received FDA 510(k) clearance on 1979-03-19 under 510(k) number K790468. 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 IMPLANTABLE HEART LEAD EXTENDER?

IMPLANTABLE HEART LEAD EXTENDER is a medical device that received FDA 510(k) clearance on 1979-03-19. The listed applicant is Arco Medical Products Co.. The 510(k) number is K790468.

When did IMPLANTABLE HEART LEAD EXTENDER receive FDA 510(k) clearance?

IMPLANTABLE HEART LEAD EXTENDER received FDA 510(k) clearance on 1979-03-19, under 510(k) number K790468.

Who is the listed applicant for IMPLANTABLE HEART LEAD EXTENDER?

The FDA 510(k) record lists Arco Medical Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLANTABLE HEART LEAD EXTENDER?

The FDA product code for IMPLANTABLE HEART LEAD EXTENDER is DTD.

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Other records listing Arco Medical Products 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.

K802588MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.K801806EXTERNAL SILASTIC BOOT FOR CARDIAC PULSEK801241UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.K800837PROGRAMMABLE BIPOLAR CARDIAC GENERATORK800838ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.K800326ARCOLITH 3021-CARDIAC PULSE GENERATOR

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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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