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)

GENERATOR, PULSE, CARDIAC 2LU

K-Number: K770657 · 1977-04-26

ApplicantEdwards Pacemaker Systems
Decision Date1977-04-26
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GENERATOR, PULSE, CARDIAC 2LU is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Pacemaker Systems. It received FDA 510(k) clearance on 1977-04-26 under 510(k) number K770657. 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 GENERATOR, PULSE, CARDIAC 2LU?

GENERATOR, PULSE, CARDIAC 2LU is a medical device that received FDA 510(k) clearance on 1977-04-26. The listed applicant is Edwards Pacemaker Systems. The 510(k) number is K770657.

When did GENERATOR, PULSE, CARDIAC 2LU receive FDA 510(k) clearance?

GENERATOR, PULSE, CARDIAC 2LU received FDA 510(k) clearance on 1977-04-26, under 510(k) number K770657.

Who is the listed applicant for GENERATOR, PULSE, CARDIAC 2LU?

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

What is the FDA product code for GENERATOR, PULSE, CARDIAC 2LU?

The FDA product code for GENERATOR, PULSE, CARDIAC 2LU 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_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 Edwards Pacemaker Systems 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.

K791751EDWARDS PACEMAKER 30 UNIPOLAR GENERATORK79045228 UNIPOLAR AND BIPOLAR PULSE GENERATORSK781111LEAD CONVERSION KIT, MODEL 341K781144ANALYZER, PACER SYSTEM, PSA-5K781042PROLITH 23S PACEMAKERK780780MICROPULSE 22S PACEMAKER

View all 13 devices →

Related Devices (Code: DXY)

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.

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 VascularK954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic VascularK953417MINIFLEX 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.

↑