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FDA 510(k)

PIONEER CATHETER

K-Number: K072155 · 2007-10-05

ApplicantMedtronic, Inc.
Decision Date2007-10-05
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PIONEER CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2007-10-05 under 510(k) number K072155. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIONEER CATHETER?

PIONEER CATHETER is a medical device that received FDA 510(k) clearance on 2007-10-05. The listed applicant is Medtronic, Inc.. The 510(k) number is K072155.

When did PIONEER CATHETER receive FDA 510(k) clearance?

PIONEER CATHETER received FDA 510(k) clearance on 2007-10-05, under 510(k) number K072155.

Who is the listed applicant for PIONEER CATHETER?

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

What is the FDA product code for PIONEER CATHETER?

The FDA product code for PIONEER CATHETER is PDU.

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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.

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