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FDA 510(k)

STEALTH 360 ORBITAL PAD SYSTEM

K-Number: K131092 · 2013-06-24

ApplicantCardio Systems, Inc.
Decision Date2013-06-24
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STEALTH 360 ORBITAL PAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Systems, Inc.. It received FDA 510(k) clearance on 2013-06-24 under 510(k) number K131092. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEALTH 360 ORBITAL PAD SYSTEM?

STEALTH 360 ORBITAL PAD SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-24. The listed applicant is Cardio Systems, Inc.. The 510(k) number is K131092.

When did STEALTH 360 ORBITAL PAD SYSTEM receive FDA 510(k) clearance?

STEALTH 360 ORBITAL PAD SYSTEM received FDA 510(k) clearance on 2013-06-24, under 510(k) number K131092.

Who is the listed applicant for STEALTH 360 ORBITAL PAD SYSTEM?

The FDA 510(k) record lists Cardio Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STEALTH 360 ORBITAL PAD SYSTEM?

The FDA product code for STEALTH 360 ORBITAL PAD SYSTEM is MCW.

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Other records listing Cardio Systems, 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: MCW)

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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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