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FDA 510(k)

AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304

K-Number: K042623 · 2005-01-27

ApplicantSt. Jude Medical, Daig Division, Inc.
Decision Date2005-01-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Daig Division, Inc.. It received FDA 510(k) clearance on 2005-01-27 under 510(k) number K042623. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304?

AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 is a medical device that received FDA 510(k) clearance on 2005-01-27. The listed applicant is St. Jude Medical, Daig Division, Inc.. The 510(k) number is K042623.

When did AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 receive FDA 510(k) clearance?

AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 received FDA 510(k) clearance on 2005-01-27, under 510(k) number K042623.

Who is the listed applicant for AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304?

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

What is the FDA product code for AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304?

The FDA product code for AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 is DYB.

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Other records listing St. Jude Medical, Daig Division, Inc. as applicant

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Related Devices (Code: DYB)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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