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FDA 510(k)

ECHELON MICRO CATHETER, MODEL 105-5092-150

K-Number: K030688 · 2003-03-28

ApplicantMicro Therapeutics, Inc.
Decision Date2003-03-28
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECHELON MICRO CATHETER, MODEL 105-5092-150 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 2003-03-28 under 510(k) number K030688. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHELON MICRO CATHETER, MODEL 105-5092-150?

ECHELON MICRO CATHETER, MODEL 105-5092-150 is a medical device that received FDA 510(k) clearance on 2003-03-28. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K030688.

When did ECHELON MICRO CATHETER, MODEL 105-5092-150 receive FDA 510(k) clearance?

ECHELON MICRO CATHETER, MODEL 105-5092-150 received FDA 510(k) clearance on 2003-03-28, under 510(k) number K030688.

Who is the listed applicant for ECHELON MICRO CATHETER, MODEL 105-5092-150?

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 ECHELON MICRO CATHETER, MODEL 105-5092-150?

The FDA product code for ECHELON MICRO CATHETER, MODEL 105-5092-150 is KRA.

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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: KRA)

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.

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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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