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FDA 510(k)

PBC SCALP VEIN SET

K-Number: K834255 · 1984-03-12

ApplicantPhiladelphia Biologics Center
Decision Date1984-03-12
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PBC SCALP VEIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Philadelphia Biologics Center. It received FDA 510(k) clearance on 1984-03-12 under 510(k) number K834255. 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 PBC SCALP VEIN SET?

PBC SCALP VEIN SET is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Philadelphia Biologics Center. The 510(k) number is K834255.

When did PBC SCALP VEIN SET receive FDA 510(k) clearance?

PBC SCALP VEIN SET received FDA 510(k) clearance on 1984-03-12, under 510(k) number K834255.

Who is the listed applicant for PBC SCALP VEIN SET?

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

What is the FDA product code for PBC SCALP VEIN SET?

The FDA product code for PBC SCALP VEIN SET is FOZ.

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Other records listing Philadelphia Biologics Center 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.

K841717INTRAVENOUS INJECTION SETK834256PBC SYRINGE IRRIGATINGK834253PBC IV SET NON-VENTEDK834254PBC IV SET VENTEDK834252PBC EXTENSION SETK820911PBC NEEDLE BY NIPRO MED. INDUSTRIES

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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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