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FDA 510(k)

BRAIDED HIGH PRESSURE CATHETER CONNECTOR

K-Number: K905415 · 1991-08-12

ApplicantThe R Group
Decision Date1991-08-12
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BRAIDED HIGH PRESSURE CATHETER CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is The R Group. It received FDA 510(k) clearance on 1991-08-12 under 510(k) number K905415. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAIDED HIGH PRESSURE CATHETER CONNECTOR?

BRAIDED HIGH PRESSURE CATHETER CONNECTOR is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is The R Group. The 510(k) number is K905415.

When did BRAIDED HIGH PRESSURE CATHETER CONNECTOR receive FDA 510(k) clearance?

BRAIDED HIGH PRESSURE CATHETER CONNECTOR received FDA 510(k) clearance on 1991-08-12, under 510(k) number K905415.

Who is the listed applicant for BRAIDED HIGH PRESSURE CATHETER CONNECTOR?

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

What is the FDA product code for BRAIDED HIGH PRESSURE CATHETER CONNECTOR?

The FDA product code for BRAIDED HIGH PRESSURE CATHETER CONNECTOR is FOZ.

Related Clinical Trials

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.

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Other records listing The R Group 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.

K912076POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONFK911549INJECTOR FILL TUBEK905416VESSEL DILATOR

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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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