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FDA 510(k)

EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.

K-Number: K052965 · 2006-02-13

ApplicantGuidant Corporation
Decision Date2006-02-13
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corporation. It received FDA 510(k) clearance on 2006-02-13 under 510(k) number K052965. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.?

EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. is a medical device that received FDA 510(k) clearance on 2006-02-13. The listed applicant is Guidant Corporation. The 510(k) number is K052965.

When did EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. receive FDA 510(k) clearance?

EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. received FDA 510(k) clearance on 2006-02-13, under 510(k) number K052965.

Who is the listed applicant for EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.?

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

What is the FDA product code for EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.?

The FDA product code for EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. is DRB.

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Other records listing Guidant Corporation as applicant

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Related Devices (Code: DRB)

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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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