FDA 510(k)

UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493

K-Number: K922269 · 1992-11-23

ApplicantThe Heart Valve Div. Medtronic Cardiovascular Surg

Decision Date1992-11-23

Product CodeLDF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 is the device name listed in this FDA 510(k) record. The listed applicant is The Heart Valve Div. Medtronic Cardiovascular Surg. It received FDA 510(k) clearance on 1992-11-23 under 510(k) number K922269. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493?

UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 is a medical device that received FDA 510(k) clearance on 1992-11-23. The listed applicant is The Heart Valve Div. Medtronic Cardiovascular Surg. The 510(k) number is K922269.

When did UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 receive FDA 510(k) clearance?

UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 received FDA 510(k) clearance on 1992-11-23, under 510(k) number K922269.

Who is the listed applicant for UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493?

The FDA 510(k) record lists The Heart Valve Div. Medtronic Cardiovascular Surg as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493?

The FDA product code for UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 is LDF.

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Other records listing The Heart Valve Div. Medtronic Cardiovascular Surg as applicant

K980534DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H K960356POSTERIOR ANNULOPLASTY BAND (MODEL 607)K944956UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 K914602DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.