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FDA 510(k)

PROFLEX 5

K-Number: K915168 · 1992-02-19

ApplicantPeripheral Systems Group
Decision Date1992-02-19
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROFLEX 5 is the device name listed in this FDA 510(k) record. The listed applicant is Peripheral Systems Group. It received FDA 510(k) clearance on 1992-02-19 under 510(k) number K915168. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFLEX 5?

PROFLEX 5 is a medical device that received FDA 510(k) clearance on 1992-02-19. The listed applicant is Peripheral Systems Group. The 510(k) number is K915168.

When did PROFLEX 5 receive FDA 510(k) clearance?

PROFLEX 5 received FDA 510(k) clearance on 1992-02-19, under 510(k) number K915168.

Who is the listed applicant for PROFLEX 5?

The FDA 510(k) record lists Peripheral Systems Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROFLEX 5?

The FDA product code for PROFLEX 5 is LIT.

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Other records listing Peripheral Systems Group as applicant

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K940804SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATIONK934433VANTAGE DIALTAION CATHETERK932777SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETERK931327PSG DIRECTIONAL HYDROPHILIC GUIDE WIREK915554HI-TORQUE SPORT-T(TM) GUIDE WIREK914979EDM(R) INFUSION CATHETER

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Related Devices (Code: LIT)

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.

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, 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.

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