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FDA 510(k)

AIR-BAND RADIAL COMPRESSION DEVICE

K-Number: K122405 · 2012-11-09

ApplicantDatascope Corp., Cardiac Assist Division
Decision Date2012-11-09
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AIR-BAND RADIAL COMPRESSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp., Cardiac Assist Division. It received FDA 510(k) clearance on 2012-11-09 under 510(k) number K122405. 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 AIR-BAND RADIAL COMPRESSION DEVICE?

AIR-BAND RADIAL COMPRESSION DEVICE is a medical device that received FDA 510(k) clearance on 2012-11-09. The listed applicant is Datascope Corp., Cardiac Assist Division. The 510(k) number is K122405.

When did AIR-BAND RADIAL COMPRESSION DEVICE receive FDA 510(k) clearance?

AIR-BAND RADIAL COMPRESSION DEVICE received FDA 510(k) clearance on 2012-11-09, under 510(k) number K122405.

Who is the listed applicant for AIR-BAND RADIAL COMPRESSION DEVICE?

The FDA 510(k) record lists Datascope Corp., Cardiac Assist Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR-BAND RADIAL COMPRESSION DEVICE?

The FDA product code for AIR-BAND RADIAL COMPRESSION DEVICE is DXC.

Related Clinical Trials

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Other records listing Datascope Corp., Cardiac Assist Division 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.

K122628SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIESK120868MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETERK091449DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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