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FDA 510(k)

GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION

K-Number: K905463 · 1991-01-22

ApplicantAngiosystems, Inc.
Decision Date1991-01-22
Product CodeFOZ
Advisory CommitteeHO
DecisionUnknown

Device Summary

GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION is the device name listed in this FDA 510(k) record. The listed applicant is Angiosystems, Inc.. It received FDA 510(k) clearance on 1991-01-22 under 510(k) number K905463. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION?

GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION is a medical device that received FDA 510(k) clearance on 1991-01-22. The listed applicant is Angiosystems, Inc.. The 510(k) number is K905463.

When did GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION receive FDA 510(k) clearance?

GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION received FDA 510(k) clearance on 1991-01-22, under 510(k) number K905463.

Who is the listed applicant for GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION?

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

What is the FDA product code for GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION?

The FDA product code for GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION is FOZ.

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Other records listing Angiosystems, 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.

K905464MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLINGK905459SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOMK905461PROCEDURE KIT/ROUTINE DENTAL PROCEDURESK905466STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPEK905465STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPEK905460STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY

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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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