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FDA 510(k)

MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300

K-Number: K061063 · 2006-05-18

ApplicantFoxhollow Technologies, Inc.
Decision Date2006-05-18
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 is the device name listed in this FDA 510(k) record. The listed applicant is Foxhollow Technologies, Inc.. It received FDA 510(k) clearance on 2006-05-18 under 510(k) number K061063. 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 MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300?

MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 is a medical device that received FDA 510(k) clearance on 2006-05-18. The listed applicant is Foxhollow Technologies, Inc.. The 510(k) number is K061063.

When did MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 receive FDA 510(k) clearance?

MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 received FDA 510(k) clearance on 2006-05-18, under 510(k) number K061063.

Who is the listed applicant for MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300?

The FDA 510(k) record lists Foxhollow Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300?

The FDA product code for MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 is MCW.

Related Clinical Trials

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.

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Other records listing Foxhollow Technologies, Inc. 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.

K061188SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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