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FDA 510(k)

SecurePortIV Catheter Securement Adhesive

K-Number: K170505 · 2017-09-29

ApplicantAdhezion Biomedical, LLC
Decision Date2017-09-29
Product CodeNZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SecurePortIV 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 2017-09-29 under 510(k) number K170505. 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 Catheter Securement Adhesive?

SecurePortIV Catheter Securement Adhesive is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Adhezion Biomedical, LLC. The 510(k) number is K170505.

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

SecurePortIV Catheter Securement Adhesive received FDA 510(k) clearance on 2017-09-29, under 510(k) number K170505.

Who is the listed applicant for SecurePortIV 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 Catheter Securement Adhesive?

The FDA product code for SecurePortIV 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.

K223669SecurePortIV Advanced 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.

K223669SecurePortIV Advanced Catheter Securement AdhesiveAdhezion Biomedical, LLC

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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