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FDA 510(k)

20G x 5/8 Pro-Lock CT Safety Infusion Set

K-Number: K171333 · 2017-07-18

ApplicantMedcomp (Dba Medical Components, Inc.)
Decision Date2017-07-18
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

20G x 5/8 Pro-Lock CT Safety Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Dba Medical Components, Inc.). It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K171333. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 20G x 5/8 Pro-Lock CT Safety Infusion Set?

20G x 5/8 Pro-Lock CT Safety Infusion Set is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Medcomp (Dba Medical Components, Inc.). The 510(k) number is K171333.

When did 20G x 5/8 Pro-Lock CT Safety Infusion Set receive FDA 510(k) clearance?

20G x 5/8 Pro-Lock CT Safety Infusion Set received FDA 510(k) clearance on 2017-07-18, under 510(k) number K171333.

Who is the listed applicant for 20G x 5/8 Pro-Lock CT Safety Infusion Set?

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

What is the FDA product code for 20G x 5/8 Pro-Lock CT Safety Infusion Set?

The FDA product code for 20G x 5/8 Pro-Lock CT Safety Infusion Set is PTI.

Other records listing Medcomp (Dba 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.

K171483ArchFlo CT MidlineK171618Symetrex Long Term Hemodialysis Catheter

Related Devices (Code: PTI)

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.

K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSb-Kawasumi Laboratories, Inc.K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc.K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.K213823Intera Refill KitIntera Oncology, Inc.

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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