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 a medical device manufactured by Medcomp (Medical Components, Inc.). It received FDA 510(k) clearance on 2016-02-12 under approval 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. It is manufactured by Medcomp (Medical Components, Inc.). The 510(k) number is K153246.

When was PTFE Super Sheath Introducer 2.1 approved by the FDA?

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

What company makes PTFE Super Sheath Introducer 2.1?

PTFE Super Sheath Introducer 2.1 is manufactured by Medcomp (Medical Components, Inc.).

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 Devices by Medcomp (Medical Components, Inc.)

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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.