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FDA 510(k)

PTFE Super Sheath Introducer 2.1

K-Number: K153246 · 2016-02-12

ApplicantMedcomp (Medical Components, Inc.)
Decision Date2016-02-12
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTFE Super Sheath Introducer 2.1 is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Medical Components, Inc.). It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K153246. 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 2.1?

PTFE Super Sheath Introducer 2.1 is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Medcomp (Medical Components, Inc.). The 510(k) number is K153246.

When did PTFE Super Sheath Introducer 2.1 receive FDA 510(k) clearance?

PTFE Super Sheath Introducer 2.1 received FDA 510(k) clearance on 2016-02-12, under 510(k) number K153246.

Who is the listed applicant for PTFE Super Sheath Introducer 2.1?

The FDA 510(k) record lists Medcomp (Medical Components, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PTFE Super Sheath Introducer 2.1?

The FDA product code for PTFE Super Sheath Introducer 2.1 is DYB.

Other records listing Medcomp (Medical Components, 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.

K171931Celerity ECG Cable Accessory PackK162389Medcomp Vessel DilatorK162271Pro-Lock CT Safety Infusion SetK153238Dignity Dual Port

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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