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FDA 510(k)

UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492

K-Number: K944966 · 1995-07-14

Decision Date1995-07-14
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Blood Systems, Inc.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K944966. 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 ATRIAL TEMPORARY PACING LEAD,MODEL 6492?

UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Medtronic Blood Systems, Inc.. The 510(k) number is K944966.

When did UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 receive FDA 510(k) clearance?

UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 received FDA 510(k) clearance on 1995-07-14, under 510(k) number K944966.

Who is the listed applicant for UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492?

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

What is the FDA product code for UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492?

The FDA product code for UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 is LDF.

Related Clinical Trials

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.

Other records listing Medtronic Blood Systems, Inc. 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.

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Related Devices (Code: LDF)

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.

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.

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