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FDA 510(k)

CLEANER ROTATIONAL THROMBECTOMY SYSTEM

K-Number: K120346 · 2012-06-01

ApplicantRex Medical
Decision Date2012-06-01
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLEANER ROTATIONAL THROMBECTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rex Medical. It received FDA 510(k) clearance on 2012-06-01 under 510(k) number K120346. 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 CLEANER ROTATIONAL THROMBECTOMY SYSTEM?

CLEANER ROTATIONAL THROMBECTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-01. The listed applicant is Rex Medical. The 510(k) number is K120346.

When did CLEANER ROTATIONAL THROMBECTOMY SYSTEM receive FDA 510(k) clearance?

CLEANER ROTATIONAL THROMBECTOMY SYSTEM received FDA 510(k) clearance on 2012-06-01, under 510(k) number K120346.

Who is the listed applicant for CLEANER ROTATIONAL THROMBECTOMY SYSTEM?

The FDA 510(k) record lists Rex Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEANER ROTATIONAL THROMBECTOMY SYSTEM?

The FDA product code for CLEANER ROTATIONAL THROMBECTOMY SYSTEM is MCW.

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Other records listing Rex Medical 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.

K113103SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICEK102043ULTRASTREAM CHRONIC HEMODIALYSIS CATHETERK091029CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)K081410OPTION VENA CAVA FILTERK07142215.5F HEMO-STREAM HEMODIALYSIS CATHETER SETK051468INNER-LOCK INTRODUCER SHEATH

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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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