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FDA 510(k)

STIFFER COAXIAL MICRO-INTRODUCER KIT

K-Number: K071574 · 2007-07-05

ApplicantEnpath Medical, Inc.
Decision Date2007-07-05
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STIFFER COAXIAL MICRO-INTRODUCER KIT 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 2007-07-05 under 510(k) number K071574. 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 STIFFER COAXIAL MICRO-INTRODUCER KIT?

STIFFER COAXIAL MICRO-INTRODUCER KIT is a medical device that received FDA 510(k) clearance on 2007-07-05. The listed applicant is Enpath Medical, Inc.. The 510(k) number is K071574.

When did STIFFER COAXIAL MICRO-INTRODUCER KIT receive FDA 510(k) clearance?

STIFFER COAXIAL MICRO-INTRODUCER KIT received FDA 510(k) clearance on 2007-07-05, under 510(k) number K071574.

Who is the listed applicant for STIFFER COAXIAL MICRO-INTRODUCER KIT?

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 STIFFER COAXIAL MICRO-INTRODUCER KIT?

The FDA product code for STIFFER COAXIAL MICRO-INTRODUCER KIT is DYB.

Related Clinical Trials

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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 INTRODUCERK063182ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXXK061119ENPATH MEDICAL STEERABLE SHEATH

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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