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FDA 510(k)

AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)

K-Number: K971984 · 1997-09-19

ApplicantMicrovena Corp.
Decision Date1997-09-19
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) is the device name listed in this FDA 510(k) record. The listed applicant is Microvena Corp.. It received FDA 510(k) clearance on 1997-09-19 under 510(k) number K971984. 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 AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)?

AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) is a medical device that received FDA 510(k) clearance on 1997-09-19. The listed applicant is Microvena Corp.. The 510(k) number is K971984.

When did AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) receive FDA 510(k) clearance?

AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) received FDA 510(k) clearance on 1997-09-19, under 510(k) number K971984.

Who is the listed applicant for AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)?

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

What is the FDA product code for AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)?

The FDA product code for AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) is MCW.

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Other records listing Microvena 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.

K991898ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIREK991194MODIFICATION TO ULTRA-SELECT GUIDEWIREK982657AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100K970668THE AMPLANTZ GOOSE NECK MICROSNAREK972511AMPLATZ GOOSE NECK SNARE KIT/ CATHETERK954642HYDRO-SELECT GUIDEWIRE

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Related Devices (Code: MCW)

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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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