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FDA 510(k)

RETRACTA DETACHABLE EMBOLIZATION COIL

K-Number: K123712 · 2013-01-03

ApplicantCook Incorporated
Decision Date2013-01-03
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RETRACTA DETACHABLE EMBOLIZATION COIL is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2013-01-03 under 510(k) number K123712. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETRACTA DETACHABLE EMBOLIZATION COIL?

RETRACTA DETACHABLE EMBOLIZATION COIL is a medical device that received FDA 510(k) clearance on 2013-01-03. The listed applicant is Cook Incorporated. The 510(k) number is K123712.

When did RETRACTA DETACHABLE EMBOLIZATION COIL receive FDA 510(k) clearance?

RETRACTA DETACHABLE EMBOLIZATION COIL received FDA 510(k) clearance on 2013-01-03, under 510(k) number K123712.

Who is the listed applicant for RETRACTA DETACHABLE EMBOLIZATION COIL?

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

What is the FDA product code for RETRACTA DETACHABLE EMBOLIZATION COIL?

The FDA product code for RETRACTA DETACHABLE EMBOLIZATION COIL is KRD.

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Related Devices (Code: KRD)

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.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

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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