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FDA 510(k)

KEYST0NE MEDICAL PICC CATHETER

K-Number: K011860 · 2001-06-27

ApplicantKeystone Medical
Decision Date2001-06-27
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KEYST0NE MEDICAL PICC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Medical. It received FDA 510(k) clearance on 2001-06-27 under 510(k) number K011860. 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 KEYST0NE MEDICAL PICC CATHETER?

KEYST0NE MEDICAL PICC CATHETER is a medical device that received FDA 510(k) clearance on 2001-06-27. The listed applicant is Keystone Medical. The 510(k) number is K011860.

When did KEYST0NE MEDICAL PICC CATHETER receive FDA 510(k) clearance?

KEYST0NE MEDICAL PICC CATHETER received FDA 510(k) clearance on 2001-06-27, under 510(k) number K011860.

Who is the listed applicant for KEYST0NE MEDICAL PICC CATHETER?

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

What is the FDA product code for KEYST0NE MEDICAL PICC CATHETER?

The FDA product code for KEYST0NE MEDICAL PICC CATHETER 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 Keystone Medical 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.

K001958KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH

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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