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FDA 510(k)

SOLITAIRE FR REVASCULARIZATION DEVICE

K-Number: K113455 · 2012-03-02

ApplicantMicro Therapeutics Dba Ev3 Neurovascular
Decision Date2012-03-02
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOLITAIRE FR REVASCULARIZATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics Dba Ev3 Neurovascular. It received FDA 510(k) clearance on 2012-03-02 under 510(k) number K113455. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLITAIRE FR REVASCULARIZATION DEVICE?

SOLITAIRE FR REVASCULARIZATION DEVICE is a medical device that received FDA 510(k) clearance on 2012-03-02. The listed applicant is Micro Therapeutics Dba Ev3 Neurovascular. The 510(k) number is K113455.

When did SOLITAIRE FR REVASCULARIZATION DEVICE receive FDA 510(k) clearance?

SOLITAIRE FR REVASCULARIZATION DEVICE received FDA 510(k) clearance on 2012-03-02, under 510(k) number K113455.

Who is the listed applicant for SOLITAIRE FR REVASCULARIZATION DEVICE?

The FDA 510(k) record lists Micro Therapeutics Dba Ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLITAIRE FR REVASCULARIZATION DEVICE?

The FDA product code for SOLITAIRE FR REVASCULARIZATION DEVICE is NRY.

Related Clinical Trials

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Other records listing Micro Therapeutics Dba Ev3 Neurovascular 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.

K123378SOLITAIRE 2 REVASCULARIZATION DEVICEK101570HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS

Related Devices (Code: NRY)

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.

K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing KitMaduro Medical, Inc.K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd.K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, 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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