FDA 510(k)

DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS

K-Number: K862226 · 1987-02-03

Decision Date1987-02-03

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1987-02-03 under 510(k) number K862226. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS?

DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS is a medical device that received FDA 510(k) clearance on 1987-02-03. The listed applicant is Pacesetter Systems. The 510(k) number is K862226.

When did DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS receive FDA 510(k) clearance?

DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS received FDA 510(k) clearance on 1987-02-03, under 510(k) number K862226.

Who is the listed applicant for DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS?

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

What is the FDA product code for DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS?

The FDA product code for DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS is DXY. This falls under the Clinical Chemistry category.

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 Pacesetter Systems as applicant

K910924ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE K902147ENDOCARDIAL SCREW-IN LEAD MODEL 1028T K900512SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS K900550FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T K895447ENDOCARDIAL SCREW-IN LEAD MODEL 1020T K891905CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

View all 96 devices →

Related Devices (Code: DXY)

K993434PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-ABiotronik, Inc.K970072OPUS S MODEL 4121 AND 4124 PACEMAKERSEla Medical, Inc.K945627PIKOS LP 01, PIKOS LP E01Biotronik, Inc.K953866MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)Medtronic Vascular K954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic Vascular K953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSCook Pacemaker Corp.

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.