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FDA 510(k)

COMFORT-Q SUBCUTANEOUS INJECTION SETS

K-Number: K946170 · 1995-11-03

ApplicantB. Braun of America, Inc.
Decision Date1995-11-03
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFORT-Q SUBCUTANEOUS INJECTION SETS is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun of America, Inc.. It received FDA 510(k) clearance on 1995-11-03 under 510(k) number K946170. 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 COMFORT-Q SUBCUTANEOUS INJECTION SETS?

COMFORT-Q SUBCUTANEOUS INJECTION SETS is a medical device that received FDA 510(k) clearance on 1995-11-03. The listed applicant is B. Braun of America, Inc.. The 510(k) number is K946170.

When did COMFORT-Q SUBCUTANEOUS INJECTION SETS receive FDA 510(k) clearance?

COMFORT-Q SUBCUTANEOUS INJECTION SETS received FDA 510(k) clearance on 1995-11-03, under 510(k) number K946170.

Who is the listed applicant for COMFORT-Q SUBCUTANEOUS INJECTION SETS?

The FDA 510(k) record lists B. Braun of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFORT-Q SUBCUTANEOUS INJECTION SETS?

The FDA product code for COMFORT-Q SUBCUTANEOUS INJECTION SETS is FOZ.

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Other records listing B. Braun of America, 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.

K993024CELSITE IMPLANTABLE PORT WITH VALVED CATHETERK983794CHEMO MINI SPIKE PLUSK945850BRAUN DIACAN(R) FISTULA NEEDLESK942988FILTERED EXTENSION SETSK945752CELSITE(TM) BRACHIAL VENOUS PORTK945551CELSITE(TM) DUAL VENOUS SYSTEM

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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

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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