Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE

K-Number: K090286 · 2009-03-23

ApplicantAdvanced Vascular Dynamics
Decision Date2009-03-23
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Vascular Dynamics. It received FDA 510(k) clearance on 2009-03-23 under 510(k) number K090286. 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 PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE?

PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE is a medical device that received FDA 510(k) clearance on 2009-03-23. The listed applicant is Advanced Vascular Dynamics. The 510(k) number is K090286.

When did PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE receive FDA 510(k) clearance?

PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE received FDA 510(k) clearance on 2009-03-23, under 510(k) number K090286.

Who is the listed applicant for PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE?

The FDA 510(k) record lists Advanced Vascular Dynamics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE?

The FDA product code for PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Advanced Vascular Dynamics 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.

K093192FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICEK092503RADAR VASCULAR COMPRESSION DEVICESK072167COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICEK040615COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM

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.

↑