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FDA 510(k)

BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM

K-Number: K051817 · 2006-12-06

ApplicantCardiva Medical, Inc.
Decision Date2006-12-06
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardiva Medical, Inc.. It received FDA 510(k) clearance on 2006-12-06 under 510(k) number K051817. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM?

BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-06. The listed applicant is Cardiva Medical, Inc.. The 510(k) number is K051817.

When did BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM receive FDA 510(k) clearance?

BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM received FDA 510(k) clearance on 2006-12-06, under 510(k) number K051817.

Who is the listed applicant for BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM?

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

What is the FDA product code for BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM?

The FDA product code for BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM is DXC.

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Other records listing Cardiva Medical, 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.

K130124CATALYST II AND IIIK082930CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATEK072297BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEMK070485BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58LK061075BOOMERANG WIREK041486VASOSTASIS VASCULAR CLOSURE SYSTEM

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Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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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