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FDA 510(k)

SecurePortIV Advanced Catheter Securement Adhesive

K-Number: K223669 · 2023-06-12

ApplicantAdhezion Biomedical, LLC
Decision Date2023-06-12
Product CodeNZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SecurePortIV Advanced Catheter Securement Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Adhezion Biomedical, LLC. It received FDA 510(k) clearance on 2023-06-12 under 510(k) number K223669. The device is classified under product code NZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SecurePortIV Advanced Catheter Securement Adhesive?

SecurePortIV Advanced Catheter Securement Adhesive is a medical device that received FDA 510(k) clearance on 2023-06-12. The listed applicant is Adhezion Biomedical, LLC. The 510(k) number is K223669.

When did SecurePortIV Advanced Catheter Securement Adhesive receive FDA 510(k) clearance?

SecurePortIV Advanced Catheter Securement Adhesive received FDA 510(k) clearance on 2023-06-12, under 510(k) number K223669.

Who is the listed applicant for SecurePortIV Advanced Catheter Securement Adhesive?

The FDA 510(k) record lists Adhezion Biomedical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SecurePortIV Advanced Catheter Securement Adhesive?

The FDA product code for SecurePortIV Advanced Catheter Securement Adhesive is NZP.

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.

NCT06770374Effectiveness of a Zinc Oxide Adhesive Securement Device in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult PatientsRECRUITINGNCT07697430Medical Adhesive and Barrier Products for Preventing MARSI in Central Venous Catheter DressingsRECRUITING

Other records listing Adhezion Biomedical, LLC 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.

K170505SecurePortIV Catheter Securement AdhesiveK161011SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive

Related Devices (Code: NZP)

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.

K170505SecurePortIV Catheter Securement AdhesiveAdhezion Biomedical, LLC

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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