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FDA 510(k)

VIAPEEL PEELABLE INTRODUCER

K-Number: K072248 · 2007-11-09

ApplicantEnpath Medical, Inc.
Decision Date2007-11-09
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIAPEEL PEELABLE INTRODUCER 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 2007-11-09 under 510(k) number K072248. 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 VIAPEEL PEELABLE INTRODUCER?

VIAPEEL PEELABLE INTRODUCER is a medical device that received FDA 510(k) clearance on 2007-11-09. The listed applicant is Enpath Medical, Inc.. The 510(k) number is K072248.

When did VIAPEEL PEELABLE INTRODUCER receive FDA 510(k) clearance?

VIAPEEL PEELABLE INTRODUCER received FDA 510(k) clearance on 2007-11-09, under 510(k) number K072248.

Who is the listed applicant for VIAPEEL PEELABLE INTRODUCER?

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 VIAPEEL PEELABLE INTRODUCER?

The FDA product code for VIAPEEL PEELABLE INTRODUCER is DYB.

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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 INTRODUCERSK071574STIFFER COAXIAL MICRO-INTRODUCER KITK063182ENPATH 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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