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)

PACEMAKER, PERM. & TEMP., ELECTRODE

K-Number: K772197 · 1978-01-30

ApplicantDaig Corp.
Decision Date1978-01-30
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEMAKER, PERM. & TEMP., ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Daig Corp.. It received FDA 510(k) clearance on 1978-01-30 under 510(k) number K772197. 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 PACEMAKER, PERM. & TEMP., ELECTRODE?

PACEMAKER, PERM. & TEMP., ELECTRODE is a medical device that received FDA 510(k) clearance on 1978-01-30. The listed applicant is Daig Corp.. The 510(k) number is K772197.

When did PACEMAKER, PERM. & TEMP., ELECTRODE receive FDA 510(k) clearance?

PACEMAKER, PERM. & TEMP., ELECTRODE received FDA 510(k) clearance on 1978-01-30, under 510(k) number K772197.

Who is the listed applicant for PACEMAKER, PERM. & TEMP., ELECTRODE?

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

What is the FDA product code for PACEMAKER, PERM. & TEMP., ELECTRODE?

The FDA product code for PACEMAKER, PERM. & TEMP., ELECTRODE 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 Daig Corp. 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.

K000004ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509K994334ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXXK982299SPYGLASS 5 FR ANGIOGRAPHIC CATHETERK982187FAST-CATH INTRA-CARDIAC INTRODUCERK973840FAST-CATH (TM) INTRA-CARDIAC INTRODUCERK964518FAST-CATH TRANSSEPTAL CATHETER INTRODUCER

View all 63 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.

↑