FDA 510(k)

SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924

K-Number: K010737 · 2001-04-04

ApplicantMedtronic Cardiac Surgical Products

Decision Date2001-04-04

Product CodeDWF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 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 2001-04-04 under 510(k) number K010737. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924?

SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 is a medical device that received FDA 510(k) clearance on 2001-04-04. The listed applicant is Medtronic Cardiac Surgical Products. The 510(k) number is K010737.

When did SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 receive FDA 510(k) clearance?

SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 received FDA 510(k) clearance on 2001-04-04, under 510(k) number K010737.

Who is the listed applicant for SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924?

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 SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924?

The FDA product code for SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 is DWF.

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Other records listing Medtronic Cardiac Surgical Products as applicant

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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.