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FDA 510(k)

PERMANENT ENDOCARD. UNIPOLAR TINED LEAD

K-Number: K812905 · 1982-02-04

ApplicantDiag Corp.
Decision Date1982-02-04
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERMANENT ENDOCARD. UNIPOLAR TINED LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Diag Corp.. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K812905. 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 PERMANENT ENDOCARD. UNIPOLAR TINED LEAD?

PERMANENT ENDOCARD. UNIPOLAR TINED LEAD is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Diag Corp.. The 510(k) number is K812905.

When did PERMANENT ENDOCARD. UNIPOLAR TINED LEAD receive FDA 510(k) clearance?

PERMANENT ENDOCARD. UNIPOLAR TINED LEAD received FDA 510(k) clearance on 1982-02-04, under 510(k) number K812905.

Who is the listed applicant for PERMANENT ENDOCARD. UNIPOLAR TINED LEAD?

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 PERMANENT ENDOCARD. UNIPOLAR TINED LEAD?

The FDA product code for PERMANENT ENDOCARD. UNIPOLAR TINED LEAD is DTB.

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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.

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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.

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