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FDA 510(k)

HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS

K-Number: K101570 · 2010-07-13

ApplicantMicro Therapeutics Dba Ev3 Neurovascular
Decision Date2010-07-13
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS 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 2010-07-13 under 510(k) number K101570. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS?

HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS is a medical device that received FDA 510(k) clearance on 2010-07-13. The listed applicant is Micro Therapeutics Dba Ev3 Neurovascular. The 510(k) number is K101570.

When did HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS receive FDA 510(k) clearance?

HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS received FDA 510(k) clearance on 2010-07-13, under 510(k) number K101570.

Who is the listed applicant for HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS?

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 HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS?

The FDA product code for HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS is MJN.

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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 DEVICEK113455SOLITAIRE FR REVASCULARIZATION DEVICE

Related Devices (Code: MJN)

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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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