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FDA 510(k)

PTFE INTERLOCK PEELABLE INTRODUCERS

K-Number: K081394 · 2008-09-15

ApplicantEnpath Medical, Inc.
Decision Date2008-09-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTFE INTERLOCK PEELABLE INTRODUCERS 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 2008-09-15 under 510(k) number K081394. 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 PTFE INTERLOCK PEELABLE INTRODUCERS?

PTFE INTERLOCK PEELABLE INTRODUCERS is a medical device that received FDA 510(k) clearance on 2008-09-15. The listed applicant is Enpath Medical, Inc.. The 510(k) number is K081394.

When did PTFE INTERLOCK PEELABLE INTRODUCERS receive FDA 510(k) clearance?

PTFE INTERLOCK PEELABLE INTRODUCERS received FDA 510(k) clearance on 2008-09-15, under 510(k) number K081394.

Who is the listed applicant for PTFE INTERLOCK PEELABLE INTRODUCERS?

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 PTFE INTERLOCK PEELABLE INTRODUCERS?

The FDA product code for PTFE INTERLOCK PEELABLE INTRODUCERS 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.

K072248VIAPEEL PEELABLE INTRODUCERK071574STIFFER 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

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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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