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Transfer Set Sealing Cap, Cat. No. 48-1027-1

FDA 510(k)

Class II (US FDA 510(k))

510(k) K896761

by National Medical Care, Medical Products Div., Inc.

Identifiers

510(k) Number
K896761 FDA 510(k)
FDA Product Code
KDJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5630 FDA 510(k)
Regulation Number
876.5630 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Set, Administration, For Peritoneal Dialysis, Disposable, as defined in the device name and specifications. It is a sterile, single-use protective cap designed to securely seal and protect the end of a peritoneal dialysis transfer set when not in use.

It is supplied sterile and intended for single use to prevent microbial contamination and reduce the risk of peritonitis. The device has FDA 510(k) clearance under K896761 and is classified as a Class II medical device for use in peritoneal dialysis administration sets.

Frequently asked questions

What is the Transfer Set Sealing Cap used for?

It is a sterile, single-use protective cap designed to securely seal and protect the end of a peritoneal dialysis transfer set when not in use, preventing microbial contamination and reducing the risk of peritonitis.

Is the Transfer Set Sealing Cap sterile and for single use only?

Yes, the device is supplied sterile and intended for single use to prevent microbial contamination and reduce the risk of peritonitis, as specified in its description and intended use.

What regulatory clearance does the Transfer Set Sealing Cap have?

The device has FDA 510(k) clearance under K896761 and is classified as a Class II medical device for use in peritoneal dialysis administration sets.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Transfer Set Sealing Cap, Cat. No. 48-1027-1, PDF K896761 Transfer Set Sealing Cap, Cat. No. 48-1027-1, 510 (k) Premarket Notification - Food and Drug Administration, Stockmed Offer Products

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
National Medical Care, Medical Products Div., Inc.

Sources (1)

  • FDA 510(k) K896761 24 fields · synced Sep 21, 2026