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FDA 510(k)

THROMCAT THROMBECTOMY CATHETER SYSTEM

K-Number: K072195 · 2007-08-23

ApplicantKensey Nash Corp.
Decision Date2007-08-23
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THROMCAT THROMBECTOMY CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corp.. It received FDA 510(k) clearance on 2007-08-23 under 510(k) number K072195. 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 THROMCAT THROMBECTOMY CATHETER SYSTEM?

THROMCAT THROMBECTOMY CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-23. The listed applicant is Kensey Nash Corp.. The 510(k) number is K072195.

When did THROMCAT THROMBECTOMY CATHETER SYSTEM receive FDA 510(k) clearance?

THROMCAT THROMBECTOMY CATHETER SYSTEM received FDA 510(k) clearance on 2007-08-23, under 510(k) number K072195.

Who is the listed applicant for THROMCAT THROMBECTOMY CATHETER SYSTEM?

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

What is the FDA product code for THROMCAT THROMBECTOMY CATHETER SYSTEM?

The FDA product code for THROMCAT THROMBECTOMY CATHETER SYSTEM is MCW.

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Other records listing Kensey Nash Corp. 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.

K103787MEDEOR MATRIXK091192KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XXK091499MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)K090919KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANEK073519QUICKCAT EXTRACTION CATHETER, MODEL 60090-01K071695KENSEY NASH MACROPORE SHIELD

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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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