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FDA 510(k)

EXEL SAFELET CATHETER

K-Number: K895768 · 1990-02-16

ApplicantExel Intl.
Decision Date1990-02-16
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXEL SAFELET CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Exel Intl.. It received FDA 510(k) clearance on 1990-02-16 under 510(k) number K895768. 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 EXEL SAFELET CATHETER?

EXEL SAFELET CATHETER is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Exel Intl.. The 510(k) number is K895768.

When did EXEL SAFELET CATHETER receive FDA 510(k) clearance?

EXEL SAFELET CATHETER received FDA 510(k) clearance on 1990-02-16, under 510(k) number K895768.

Who is the listed applicant for EXEL SAFELET CATHETER?

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

What is the FDA product code for EXEL SAFELET CATHETER?

The FDA product code for EXEL SAFELET CATHETER is FOZ.

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Other records listing Exel Intl. 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.

K992290EXEL INJECTION PLUG WITH CAPK963658EXEL AVF SINGLE NEEDLEK963659EXEL I.V. ADMINISTRATION SETK926119EXEL HUBER INFUSION SET ROTATING WINGK904685EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)K903945EXEL A-V FISTULA SET

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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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