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FDA 510(k)

NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER

K-Number: K131425 · 2013-08-14

ApplicantMedtronic Navigation, Inc.
Decision Date2013-08-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2013-08-14 under 510(k) number K131425. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER?

NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER is a medical device that received FDA 510(k) clearance on 2013-08-14. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K131425.

When did NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER receive FDA 510(k) clearance?

NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER received FDA 510(k) clearance on 2013-08-14, under 510(k) number K131425.

Who is the listed applicant for NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER?

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

What is the FDA product code for NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER?

The FDA product code for NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER is OLO.

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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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