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FDA 510(k)

Patent Hemostasis Band (PH Band)

K-Number: K201695 · 2020-10-30

ApplicantMedical Ingenuities
Decision Date2020-10-30
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patent Hemostasis Band (PH Band) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Ingenuities. It received FDA 510(k) clearance on 2020-10-30 under 510(k) number K201695. 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 Patent Hemostasis Band (PH Band)?

Patent Hemostasis Band (PH Band) is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Medical Ingenuities. The 510(k) number is K201695.

When did Patent Hemostasis Band (PH Band) receive FDA 510(k) clearance?

Patent Hemostasis Band (PH Band) received FDA 510(k) clearance on 2020-10-30, under 510(k) number K201695.

Who is the listed applicant for Patent Hemostasis Band (PH Band)?

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

What is the FDA product code for Patent Hemostasis Band (PH Band)?

The FDA product code for Patent Hemostasis Band (PH Band) is DXC.

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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