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FDA 510(k)

MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM

K-Number: K080206 · 2008-02-26

ApplicantRadi Medical Systems AB
Decision Date2008-02-26
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radi Medical Systems AB. It received FDA 510(k) clearance on 2008-02-26 under 510(k) number K080206. 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 MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM?

MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-26. The listed applicant is Radi Medical Systems AB. The 510(k) number is K080206.

When did MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM received FDA 510(k) clearance on 2008-02-26, under 510(k) number K080206.

Who is the listed applicant for MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM?

The FDA 510(k) record lists Radi Medical Systems AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM?

The FDA product code for MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM is DXC.

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Other records listing Radi Medical Systems AB 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.

K123984QUANTIEN MEASUREMENT SYSTEMK092105RADIANALYZER XPRESSK080813PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVERK062769PRESSUREWIRE CERTUS, MODELS 12006 AND 12306K042628MODIFICATION TO: RADIANALYZER, MODEL 12711K033291TOPSEAL HEMOSTATIC DRESSING, MODEL 11150

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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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