FDA 510(k)

UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491

K-Number: K944956 · 1995-07-14

ApplicantThe Heart Valve Div. Medtronic Cardiovascular Surg

Decision Date1995-07-14

Product CodeLDF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 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 1995-07-14 under 510(k) number K944956. 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 PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491?

UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is The Heart Valve Div. Medtronic Cardiovascular Surg. The 510(k) number is K944956.

When did UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 receive FDA 510(k) clearance?

UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 received FDA 510(k) clearance on 1995-07-14, under 510(k) number K944956.

Who is the listed applicant for UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491?

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 PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491?

The FDA product code for UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 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)K922269UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 K914602DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED

Related Devices (Code: LDF)

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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.