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FDA 510(k)

MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER

K-Number: K870323 · 1987-03-03

ApplicantPace Medical
Decision Date1987-03-03
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER is the device name listed in this FDA 510(k) record. The listed applicant is Pace Medical. It received FDA 510(k) clearance on 1987-03-03 under 510(k) number K870323. 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 MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER?

MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER is a medical device that received FDA 510(k) clearance on 1987-03-03. The listed applicant is Pace Medical. The 510(k) number is K870323.

When did MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER receive FDA 510(k) clearance?

MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER received FDA 510(k) clearance on 1987-03-03, under 510(k) number K870323.

Who is the listed applicant for MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER?

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

What is the FDA product code for MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER?

The FDA product code for MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER is DTE.

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Other records listing Pace Medical 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.

K011980ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825K012392DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260K002204PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265VK002496MODEL 4815 ADAPTERK002497MODEL 4810 ANALYZER OUTPUT ADAPTERK001180TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528

View all 19 devices →

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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