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FDA 510(k)

SAFECATH

K-Number: K880260 · 1988-04-19

ApplicantPhase Medical Systems, Inc.
Decision Date1988-04-19
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFECATH is the device name listed in this FDA 510(k) record. The listed applicant is Phase Medical Systems, Inc.. It received FDA 510(k) clearance on 1988-04-19 under 510(k) number K880260. 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 SAFECATH?

SAFECATH is a medical device that received FDA 510(k) clearance on 1988-04-19. The listed applicant is Phase Medical Systems, Inc.. The 510(k) number is K880260.

When did SAFECATH receive FDA 510(k) clearance?

SAFECATH received FDA 510(k) clearance on 1988-04-19, under 510(k) number K880260.

Who is the listed applicant for SAFECATH?

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

What is the FDA product code for SAFECATH?

The FDA product code for SAFECATH is FOZ.

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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

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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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