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FDA 510(k)

IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY

K-Number: K854997 · 1986-02-12

ApplicantTelectronics, Inc.
Decision Date1986-02-12
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1986-02-12 under 510(k) number K854997. 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 ELECTRODE ADAPTOR ASSEMBLY?

IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY is a medical device that received FDA 510(k) clearance on 1986-02-12. The listed applicant is Telectronics, Inc.. The 510(k) number is K854997.

When did IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY receive FDA 510(k) clearance?

IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY received FDA 510(k) clearance on 1986-02-12, under 510(k) number K854997.

Who is the listed applicant for IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY?

The FDA 510(k) record lists Telectronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY?

The FDA product code for IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY is DTD.

Related Clinical Trials

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Other records listing Telectronics, Inc. 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.

K890895IMPLANTABLE ADAPTOR 033-380K891231OPTIMA MPT AND SPT PACEMAKERSK890350VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)K884411OPTIMA MPT AND SPT PACEMAKERSK884278IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436K881837OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D

View all 107 devices →

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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