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FDA 510(k)

ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90

K-Number: K042187 · 2004-09-02

ApplicantMicro Therapeutics, Inc.
Decision Date2004-09-02
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 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 2004-09-02 under 510(k) number K042187. 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 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90?

ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 is a medical device that received FDA 510(k) clearance on 2004-09-02. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K042187.

When did ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 receive FDA 510(k) clearance?

ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 received FDA 510(k) clearance on 2004-09-02, under 510(k) number K042187.

Who is the listed applicant for ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90?

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 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90?

The FDA product code for ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 is KRA.

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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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