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FDA 510(k)

ORION MICRO CATHETER

K-Number: K113289 · 2012-08-01

ApplicantMicro Therapeutics, Inc.
Decision Date2012-08-01
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ORION MICRO CATHETER 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 2012-08-01 under 510(k) number K113289. 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 ORION MICRO CATHETER?

ORION MICRO CATHETER is a medical device that received FDA 510(k) clearance on 2012-08-01. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K113289.

When did ORION MICRO CATHETER receive FDA 510(k) clearance?

ORION MICRO CATHETER received FDA 510(k) clearance on 2012-08-01, under 510(k) number K113289.

Who is the listed applicant for ORION MICRO CATHETER?

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 ORION MICRO CATHETER?

The FDA product code for ORION MICRO CATHETER 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.

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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.

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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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