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FDA 510(k)

STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078

K-Number: K090163 · 2009-04-01

ApplicantSt Jude Medical
Decision Date2009-04-01
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2009-04-01 under 510(k) number K090163. 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 STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078?

STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 is a medical device that received FDA 510(k) clearance on 2009-04-01. The listed applicant is St Jude Medical. The 510(k) number is K090163.

When did STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 receive FDA 510(k) clearance?

STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 received FDA 510(k) clearance on 2009-04-01, under 510(k) number K090163.

Who is the listed applicant for STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078?

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

What is the FDA product code for STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078?

The FDA product code for STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 is DRB.

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Related Devices (Code: DRB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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