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FDA 510(k)

PACEMAKER ELECTRODE INSERTER AIDE

K-Number: K800088 · 1980-01-29

ApplicantTelectronics, Inc.
Decision Date1980-01-29
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEMAKER ELECTRODE INSERTER AIDE is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1980-01-29 under 510(k) number K800088. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACEMAKER ELECTRODE INSERTER AIDE?

PACEMAKER ELECTRODE INSERTER AIDE is a medical device that received FDA 510(k) clearance on 1980-01-29. The listed applicant is Telectronics, Inc.. The 510(k) number is K800088.

When did PACEMAKER ELECTRODE INSERTER AIDE receive FDA 510(k) clearance?

PACEMAKER ELECTRODE INSERTER AIDE received FDA 510(k) clearance on 1980-01-29, under 510(k) number K800088.

Who is the listed applicant for PACEMAKER ELECTRODE INSERTER AIDE?

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 PACEMAKER ELECTRODE INSERTER AIDE?

The FDA product code for PACEMAKER ELECTRODE INSERTER AIDE is DTE.

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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

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Related Devices (Code: DTE)

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.

K241781Solo Pace ControlSolo Pace, Inc.K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, 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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