Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Pro-Lock CT Safety Infusion Set

K-Number: K162271 · 2017-04-26

ApplicantMedcomp (Medical Components, Inc.)
Decision Date2017-04-26
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Pro-Lock CT Safety Infusion Set 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 2017-04-26 under 510(k) number K162271. 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 Pro-Lock CT Safety Infusion Set?

Pro-Lock CT Safety Infusion Set is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Medcomp (Medical Components, Inc.). The 510(k) number is K162271.

When did Pro-Lock CT Safety Infusion Set receive FDA 510(k) clearance?

Pro-Lock CT Safety Infusion Set received FDA 510(k) clearance on 2017-04-26, under 510(k) number K162271.

Who is the listed applicant for Pro-Lock CT Safety Infusion Set?

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 Pro-Lock CT Safety Infusion Set?

The FDA product code for Pro-Lock CT Safety Infusion Set is PTI.

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 DilatorK153238Dignity Dual PortK153246PTFE Super Sheath Introducer 2.1

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑