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FDA 510(k)

ENPATH SAFETY INTRODUCER

K-Number: K041708 · 2004-11-30

ApplicantEnpath Medical Incorporated
Decision Date2004-11-30
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENPATH SAFETY INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Enpath Medical Incorporated. It received FDA 510(k) clearance on 2004-11-30 under 510(k) number K041708. 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 ENPATH SAFETY INTRODUCER?

ENPATH SAFETY INTRODUCER is a medical device that received FDA 510(k) clearance on 2004-11-30. The listed applicant is Enpath Medical Incorporated. The 510(k) number is K041708.

When did ENPATH SAFETY INTRODUCER receive FDA 510(k) clearance?

ENPATH SAFETY INTRODUCER received FDA 510(k) clearance on 2004-11-30, under 510(k) number K041708.

Who is the listed applicant for ENPATH SAFETY INTRODUCER?

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

What is the FDA product code for ENPATH SAFETY INTRODUCER?

The FDA product code for ENPATH SAFETY INTRODUCER is DYB.

Related Clinical Trials

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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Other records listing Enpath Medical Incorporated 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.

K043489ENPATH DEFLECTABLE CATHETER

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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