FDA 510(k)

MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS

K-Number: K862443 · 1986-07-10

Decision Date1986-07-10

Product CodeDTB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1986-07-10 under 510(k) number K862443. 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 MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS?

MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS is a medical device that received FDA 510(k) clearance on 1986-07-10. The listed applicant is Medtronic Vascular. The 510(k) number is K862443.

When did MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS receive FDA 510(k) clearance?

MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS received FDA 510(k) clearance on 1986-07-10, under 510(k) number K862443.

Who is the listed applicant for MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS?

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

What is the FDA product code for MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS?

The FDA product code for MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS is DTB.

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Related Devices (Code: DTB)

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 Vascular K031210MODEL 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.