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FDA 510(k)

PIONEER PLUS CATHETER, MODEL PLUS 120

K-Number: K101777 · 2010-07-23

ApplicantMedtronic Vascular
Decision Date2010-07-23
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PIONEER PLUS CATHETER, MODEL PLUS 120 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2010-07-23 under 510(k) number K101777. 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 PLUS CATHETER, MODEL PLUS 120?

PIONEER PLUS CATHETER, MODEL PLUS 120 is a medical device that received FDA 510(k) clearance on 2010-07-23. The listed applicant is Medtronic Vascular. The 510(k) number is K101777.

When did PIONEER PLUS CATHETER, MODEL PLUS 120 receive FDA 510(k) clearance?

PIONEER PLUS CATHETER, MODEL PLUS 120 received FDA 510(k) clearance on 2010-07-23, under 510(k) number K101777.

Who is the listed applicant for PIONEER PLUS CATHETER, MODEL PLUS 120?

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

What is the FDA product code for PIONEER PLUS CATHETER, MODEL PLUS 120?

The FDA product code for PIONEER PLUS CATHETER, MODEL PLUS 120 is PDU.

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Related Devices (Code: 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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