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FDA 510(k)

24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524

K-Number: K012143 · 2001-10-24

ApplicantMedtronic Cardiac Surgical Products
Decision Date2001-10-24
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Cardiac Surgical Products. It received FDA 510(k) clearance on 2001-10-24 under 510(k) number K012143. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524?

24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 is a medical device that received FDA 510(k) clearance on 2001-10-24. The listed applicant is Medtronic Cardiac Surgical Products. The 510(k) number is K012143.

When did 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 receive FDA 510(k) clearance?

24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 received FDA 510(k) clearance on 2001-10-24, under 510(k) number K012143.

Who is the listed applicant for 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524?

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

What is the FDA product code for 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524?

The FDA product code for 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 is DRA.

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Other records listing Medtronic Cardiac Surgical Products 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: DRA)

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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.

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