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FDA 510(k)

TRULINE INFUSION CATHETERS

K-Number: K011937 · 2001-08-28

ApplicantMicro Therapeutics, Inc.
Decision Date2001-08-28
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRULINE INFUSION CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc.. It received FDA 510(k) clearance on 2001-08-28 under 510(k) number K011937. 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 TRULINE INFUSION CATHETERS?

TRULINE INFUSION CATHETERS is a medical device that received FDA 510(k) clearance on 2001-08-28. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K011937.

When did TRULINE INFUSION CATHETERS receive FDA 510(k) clearance?

TRULINE INFUSION CATHETERS received FDA 510(k) clearance on 2001-08-28, under 510(k) number K011937.

Who is the listed applicant for TRULINE INFUSION CATHETERS?

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

What is the FDA product code for TRULINE INFUSION CATHETERS?

The FDA product code for TRULINE INFUSION CATHETERS is FOZ.

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Other records listing Micro Therapeutics, Inc. 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.

K113289ORION MICRO CATHETERK11345414 WIRE STANDARD, 14 WIRE LSK090870ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORYK090046CONCERTO DETACHABLE COIL SYSTEMK081465AXIUM DETACHABLE COIL SYSTEMK060747FX DETACHABLE COIL SYSTEM

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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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