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FDA 510(k)

STEALTH 360 ORBITAL PAD SYSTEM

K-Number: K110389 · 2011-03-11

ApplicantCardiovascular Systems, Inc.
Decision Date2011-03-11
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 Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2011-03-11 under 510(k) number K110389. 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 2011-03-11. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K110389.

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

STEALTH 360 ORBITAL PAD SYSTEM received FDA 510(k) clearance on 2011-03-11, under 510(k) number K110389.

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

The FDA 510(k) record lists Cardiovascular 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 Cardiovascular Systems, Inc. as applicant

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Related Devices (Code: MCW)

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.

K260244Auryon Atherectomy SystemEximo MedicalK250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectraneticsK242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.

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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