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)

LITHICRON II 0403 IMPLANTABLE PACEMAKER

K-Number: K791678 · 1979-09-07

ApplicantMedcor, Inc.
Decision Date1979-09-07
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LITHICRON II 0403 IMPLANTABLE PACEMAKER is the device name listed in this FDA 510(k) record. The listed applicant is Medcor, Inc.. It received FDA 510(k) clearance on 1979-09-07 under 510(k) number K791678. 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 LITHICRON II 0403 IMPLANTABLE PACEMAKER?

LITHICRON II 0403 IMPLANTABLE PACEMAKER is a medical device that received FDA 510(k) clearance on 1979-09-07. The listed applicant is Medcor, Inc.. The 510(k) number is K791678.

When did LITHICRON II 0403 IMPLANTABLE PACEMAKER receive FDA 510(k) clearance?

LITHICRON II 0403 IMPLANTABLE PACEMAKER received FDA 510(k) clearance on 1979-09-07, under 510(k) number K791678.

Who is the listed applicant for LITHICRON II 0403 IMPLANTABLE PACEMAKER?

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

What is the FDA product code for LITHICRON II 0403 IMPLANTABLE PACEMAKER?

The FDA product code for LITHICRON II 0403 IMPLANTABLE PACEMAKER 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 Medcor, Inc. 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.

K792609LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN.K802224QUINTREX 0516 PROG. PULSE GENERATOR SYSK802223QUINTREX 0515 PROGRAMMABLE PULSE GEN.K791095LITHICRON MODEL 0401, PACEMAKERK780430LITHICRON F PROGRAMMABLE PULSE GENK771538LITHICRON MODEL 3-70C-B PULSE GENERATOR

View all 8 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.

↑