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)

ELA MEDICAL PACING LEAD MODEL PMA 860

K-Number: K810626 · 1981-03-09

ApplicantEla Medical, Inc.
Decision Date1981-03-09
Product Code
DecisionUnknown

Device Summary

ELA MEDICAL PACING LEAD MODEL PMA 860 is the device name listed in this FDA 510(k) record. The listed applicant is Ela Medical, Inc.. It received FDA 510(k) clearance on 1981-03-09 under 510(k) number K810626. FDA Decision: Unknown.

Frequently Asked Questions

What is the ELA MEDICAL PACING LEAD MODEL PMA 860?

ELA MEDICAL PACING LEAD MODEL PMA 860 is a medical device that received FDA 510(k) clearance on 1981-03-09. The listed applicant is Ela Medical, Inc.. The 510(k) number is K810626.

When did ELA MEDICAL PACING LEAD MODEL PMA 860 receive FDA 510(k) clearance?

ELA MEDICAL PACING LEAD MODEL PMA 860 received FDA 510(k) clearance on 1981-03-09, under 510(k) number K810626.

Who is the listed applicant for ELA MEDICAL PACING LEAD MODEL PMA 860?

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

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 Ela Medical, 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.

K042002SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADERK032466SPIDERVIEWK002817SYNETECK993448STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK000029STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK990727SYNEFLASH & SYNEVIEW

View all 43 devices →

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.

↑