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FDA 510(k)

PTFE SUPER SHEATH INTRODUCER

K-Number: K120617 · 2012-11-19

ApplicantMartech Medical Products
Decision Date2012-11-19
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTFE SUPER SHEATH INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Martech Medical Products. It received FDA 510(k) clearance on 2012-11-19 under 510(k) number K120617. 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 SUPER SHEATH INTRODUCER?

PTFE SUPER SHEATH INTRODUCER is a medical device that received FDA 510(k) clearance on 2012-11-19. The listed applicant is Martech Medical Products. The 510(k) number is K120617.

When did PTFE SUPER SHEATH INTRODUCER receive FDA 510(k) clearance?

PTFE SUPER SHEATH INTRODUCER received FDA 510(k) clearance on 2012-11-19, under 510(k) number K120617.

Who is the listed applicant for PTFE SUPER SHEATH INTRODUCER?

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

What is the FDA product code for PTFE SUPER SHEATH INTRODUCER?

The FDA product code for PTFE SUPER SHEATH 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 Martech Medical Products 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.

K25409525G Huber NeedleK130855PTFE SUPER SHEATH INTRODUCERK101399COAXIAL INTRODUCER SET

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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