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FDA 510(k)

DUO-CATH FEMORAL

K-Number: K771573 · 1977-09-15

ApplicantMedical Device Laboratories
Decision Date1977-09-15
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DUO-CATH FEMORAL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Laboratories. It received FDA 510(k) clearance on 1977-09-15 under 510(k) number K771573. 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 DUO-CATH FEMORAL?

DUO-CATH FEMORAL is a medical device that received FDA 510(k) clearance on 1977-09-15. The listed applicant is Medical Device Laboratories. The 510(k) number is K771573.

When did DUO-CATH FEMORAL receive FDA 510(k) clearance?

DUO-CATH FEMORAL received FDA 510(k) clearance on 1977-09-15, under 510(k) number K771573.

Who is the listed applicant for DUO-CATH FEMORAL?

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

What is the FDA product code for DUO-CATH FEMORAL?

The FDA product code for DUO-CATH FEMORAL is FOZ.

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Other records listing Medical Device Laboratories 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.

K781110BANDAGE, COMPRESSION, FISTULAID

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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