FDA 510(k)

PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V

K-Number: K002204 · 2000-10-18

Decision Date2000-10-18

Product CodeDTE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V is the device name listed in this FDA 510(k) record. The listed applicant is Pace Medical. It received FDA 510(k) clearance on 2000-10-18 under 510(k) number K002204. 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 EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V?

PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V is a medical device that received FDA 510(k) clearance on 2000-10-18. The listed applicant is Pace Medical. The 510(k) number is K002204.

When did PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V receive FDA 510(k) clearance?

PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V received FDA 510(k) clearance on 2000-10-18, under 510(k) number K002204.

Who is the listed applicant for PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V?

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 PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V?

The FDA product code for PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V is DTE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 K002497MODEL 4810 ANALYZER OUTPUT ADAPTER K002496MODEL 4815 ADAPTER K001180TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 K925143MODEL 4800 ACCUPACE PACING SYSTEM ANALYER

View all 19 devices →

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.