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FDA 510(k)

ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP

K-Number: K852446 · 1985-09-17

ApplicantDiag Corp.
Decision Date1985-09-17
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP is the device name listed in this FDA 510(k) record. The listed applicant is Diag Corp.. It received FDA 510(k) clearance on 1985-09-17 under 510(k) number K852446. 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 ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP?

ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP is a medical device that received FDA 510(k) clearance on 1985-09-17. The listed applicant is Diag Corp.. The 510(k) number is K852446.

When did ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP receive FDA 510(k) clearance?

ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP received FDA 510(k) clearance on 1985-09-17, under 510(k) number K852446.

Who is the listed applicant for ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP?

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 ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP?

The FDA product code for ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP is DTB.

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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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