FDA 510(k)

CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)

K-Number: K091029 · 2010-02-18

Decision Date2010-02-18

Product CodeMCW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) is the device name listed in this FDA 510(k) record. The listed applicant is Rex Medical. It received FDA 510(k) clearance on 2010-02-18 under 510(k) number K091029. 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 (9 MM X 65 CM) AND (9 MM X 120 CM)?

CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) is a medical device that received FDA 510(k) clearance on 2010-02-18. The listed applicant is Rex Medical. The 510(k) number is K091029.

When did CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) receive FDA 510(k) clearance?

CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) received FDA 510(k) clearance on 2010-02-18, under 510(k) number K091029.

Who is the listed applicant for CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)?

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 (9 MM X 65 CM) AND (9 MM X 120 CM)?

The FDA product code for CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) is MCW.

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Other records listing Rex Medical as applicant

K120346CLEANER ROTATIONAL THROMBECTOMY SYSTEM K113103SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE K102043ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER K081410OPTION VENA CAVA FILTER K07142215.5F HEMO-STREAM HEMODIALYSIS CATHETER SET K051468INNER-LOCK INTRODUCER SHEATH

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Related Devices (Code: MCW)

K260244Auryon Atherectomy SystemEximo Medical K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics K242757Rotarex 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.