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)

CARDIAC PACEMAKER C4000, C1000 SER.

K-Number: K791921 · 1979-10-26

ApplicantVitatron Medical BV
Decision Date1979-10-26
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC PACEMAKER C4000, C1000 SER. is the device name listed in this FDA 510(k) record. The listed applicant is Vitatron Medical BV. It received FDA 510(k) clearance on 1979-10-26 under 510(k) number K791921. 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 CARDIAC PACEMAKER C4000, C1000 SER.?

CARDIAC PACEMAKER C4000, C1000 SER. is a medical device that received FDA 510(k) clearance on 1979-10-26. The listed applicant is Vitatron Medical BV. The 510(k) number is K791921.

When did CARDIAC PACEMAKER C4000, C1000 SER. receive FDA 510(k) clearance?

CARDIAC PACEMAKER C4000, C1000 SER. received FDA 510(k) clearance on 1979-10-26, under 510(k) number K791921.

Who is the listed applicant for CARDIAC PACEMAKER C4000, C1000 SER.?

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

What is the FDA product code for CARDIAC PACEMAKER C4000, C1000 SER.?

The FDA product code for CARDIAC PACEMAKER C4000, C1000 SER. 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 Vitatron Medical BV 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.

K854790CERYX PACEMAKER MODELS 114, 314 & 614K844484HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEAK844485CERYX6, 611, CERYX 3 311 & CERYX 1 111K844483TP 1K840668ELECTRODE PACEMAKER, PERM & TEMPK831860GENERATOR, PULSE, PACEMAKER #532

View all 19 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.

↑