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)

PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL

K-Number: K812270 · 1981-09-16

ApplicantDiag Corp.
Decision Date1981-09-16
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL is the device name listed in this FDA 510(k) record. The listed applicant is Diag Corp.. It received FDA 510(k) clearance on 1981-09-16 under 510(k) number K812270. 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 PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL?

PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL is a medical device that received FDA 510(k) clearance on 1981-09-16. The listed applicant is Diag Corp.. The 510(k) number is K812270.

When did PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL receive FDA 510(k) clearance?

PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL received FDA 510(k) clearance on 1981-09-16, under 510(k) number K812270.

Who is the listed applicant for PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL?

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

What is the FDA product code for PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL?

The FDA product code for PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL 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 Diag 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.

K984062SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229K911883DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCERK910645DISPOSABLE PATIENT CABLEK852446ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIPK820003CARDIOVASCULAR TEMP. PACEMAKER ELECK820262PERMANENT & TEMPORARY PACEMAKER ELECTR.

View all 9 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.

↑