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FDA 510(k)

ENPATH MEDICAL STEERABLE SHEATH

K-Number: K061119 · 2006-05-18

ApplicantEnpath Medical, Inc.
Decision Date2006-05-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENPATH MEDICAL STEERABLE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Enpath Medical, Inc.. It received FDA 510(k) clearance on 2006-05-18 under 510(k) number K061119. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENPATH MEDICAL STEERABLE SHEATH?

ENPATH MEDICAL STEERABLE SHEATH is a medical device that received FDA 510(k) clearance on 2006-05-18. The listed applicant is Enpath Medical, Inc.. The 510(k) number is K061119.

When did ENPATH MEDICAL STEERABLE SHEATH receive FDA 510(k) clearance?

ENPATH MEDICAL STEERABLE SHEATH received FDA 510(k) clearance on 2006-05-18, under 510(k) number K061119.

Who is the listed applicant for ENPATH MEDICAL STEERABLE SHEATH?

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

What is the FDA product code for ENPATH MEDICAL STEERABLE SHEATH?

The FDA product code for ENPATH MEDICAL STEERABLE SHEATH is DQY.

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Other records listing Enpath Medical, Inc. as applicant

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.

K081394PTFE INTERLOCK PEELABLE INTRODUCERSK072248VIAPEEL PEELABLE INTRODUCERK071574STIFFER COAXIAL MICRO-INTRODUCER KITK063182ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX

Related Devices (Code: DQY)

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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