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FDA 510(k)

EMBOLIZATION COIL SYSTEM

K-Number: K992121 · 1999-12-20

ApplicantCook, Inc.
Decision Date1999-12-20
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOLIZATION COIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1999-12-20 under 510(k) number K992121. 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 EMBOLIZATION COIL SYSTEM?

EMBOLIZATION COIL SYSTEM is a medical device that received FDA 510(k) clearance on 1999-12-20. The listed applicant is Cook, Inc.. The 510(k) number is K992121.

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

EMBOLIZATION COIL SYSTEM received FDA 510(k) clearance on 1999-12-20, under 510(k) number K992121.

Who is the listed applicant for EMBOLIZATION COIL SYSTEM?

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

What is the FDA product code for EMBOLIZATION COIL SYSTEM?

The FDA product code for EMBOLIZATION COIL SYSTEM is KRD.

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Other records listing Cook, 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.

K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETK132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERK131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SETK131206COOK CERVICAL RIPENING BALLOONK132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETK122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

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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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