Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER

K-Number: K913805 · 1991-11-19

ApplicantPace Medical
Decision Date1991-11-19
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINIATURE MODELS 4562/4563/4572/4573 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 1991-11-19 under 510(k) number K913805. 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 MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER?

MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER is a medical device that received FDA 510(k) clearance on 1991-11-19. The listed applicant is Pace Medical. The 510(k) number is K913805.

When did MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER receive FDA 510(k) clearance?

MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER received FDA 510(k) clearance on 1991-11-19, under 510(k) number K913805.

Who is the listed applicant for MINIATURE MODELS 4562/4563/4572/4573 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 MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER?

The FDA product code for MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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, 5265VK002497MODEL 4810 ANALYZER OUTPUT ADAPTERK002496MODEL 4815 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.

↑