FDA 510(k)

TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528

K-Number: K001180 · 2000-06-27

Decision Date2000-06-27

Product CodeDTE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 is the device name listed in this FDA 510(k) record. The listed applicant is Pace Medical. It received FDA 510(k) clearance on 2000-06-27 under 510(k) number K001180. 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 TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528?

TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 is a medical device that received FDA 510(k) clearance on 2000-06-27. The listed applicant is Pace Medical. The 510(k) number is K001180.

When did TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 receive FDA 510(k) clearance?

TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 received FDA 510(k) clearance on 2000-06-27, under 510(k) number K001180.

Who is the listed applicant for TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528?

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 TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528?

The FDA product code for TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 is DTE.

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Other records listing Pace Medical as applicant

K011980ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 K012392DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 K002204PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V K002496MODEL 4815 ADAPTER K002497MODEL 4810 ANALYZER OUTPUT ADAPTER K925143MODEL 4800 ACCUPACE PACING SYSTEM ANALYER

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Related Devices (Code: DTE)

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.