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FDA 510(k)

PORTACLAMP FLEX

K-Number: K070380 · 2007-06-08

ApplicantCardio Life Research, S.A.
Decision Date2007-06-08
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PORTACLAMP FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Life Research, S.A.. It received FDA 510(k) clearance on 2007-06-08 under 510(k) number K070380. 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 PORTACLAMP FLEX?

PORTACLAMP FLEX is a medical device that received FDA 510(k) clearance on 2007-06-08. The listed applicant is Cardio Life Research, S.A.. The 510(k) number is K070380.

When did PORTACLAMP FLEX receive FDA 510(k) clearance?

PORTACLAMP FLEX received FDA 510(k) clearance on 2007-06-08, under 510(k) number K070380.

Who is the listed applicant for PORTACLAMP FLEX?

The FDA 510(k) record lists Cardio Life Research, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTACLAMP FLEX?

The FDA product code for PORTACLAMP FLEX is DXC.

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 Cardio Life Research, S.A. 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.

K033085PORTACLAMP

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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