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 LEADS PMC 860 PMCF 860 PBCF860

K-Number: K851731 · 1985-08-29

ApplicantEla Medical, Inc.
Decision Date1985-08-29
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 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 1985-08-29 under 510(k) number K851731. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860?

ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 is a medical device that received FDA 510(k) clearance on 1985-08-29. The listed applicant is Ela Medical, Inc.. The 510(k) number is K851731.

When did ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 receive FDA 510(k) clearance?

ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 received FDA 510(k) clearance on 1985-08-29, under 510(k) number K851731.

Who is the listed applicant for ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860?

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

What is the FDA product code for ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860?

The FDA product code for ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 is DTB.

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 →

Related Devices (Code: DTB)

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.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

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.

↑