Identifiers
- 510(k) Number
- K201452 FDA 510(k)
- FDA Product Code
- LJS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5970 FDA 510(k)
- Regulation Number
- 880.5970 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Groshong NXT PICC Catheter is a peripherally inserted central catheter (PICC), classified as an intravascular, therapeutic, long-term device intended for use greater than 30 days. It features a valve mechanism to prevent backflow and clotting, reducing the risk of occlusion while maintaining patency for prolonged intravenous access.
This device is supplied sterile and intended for single-use in clinical settings such as hospitals and outpatient care. Available in multiple lumen configurations (single-lumen and dual-lumen), it is designed for insertion into peripheral veins for central venous access. The catheter adheres to FDA 510(k) clearance under the General Hospital advisory committee classification, with a product code of LJS. Storage and handling follow standard sterile medical device protocols.
Frequently asked questions
What types of clinical settings is the Groshong NXT PICC Catheter designed for use in?
The Groshong NXT PICC Catheter is intended for use in clinical settings such as hospitals and outpatient care facilities. Its design as a peripherally inserted central catheter (PICC) with a valve mechanism for preventing backflow and clotting makes it suitable for long-term intravenous access (greater than 30 days) in these environments.
Is the Groshong NXT PICC Catheter reusable or intended for single-use only?
The Groshong NXT PICC Catheter is explicitly supplied sterile and intended for single-use only. This aligns with standard sterile medical device protocols to ensure patient safety and prevent contamination.
What lumen configurations are available for the Groshong NXT PICC Catheter?
The Groshong NXT PICC Catheter is available in single-lumen and dual-lumen configurations, allowing flexibility for different clinical needs such as administering medications, fluids, or accessing blood for monitoring.
How is the Groshong NXT PICC Catheter regulated, and what does that mean for buyers?
The Groshong NXT PICC Catheter holds an FDA 510(k) clearance under the General Hospital advisory committee classification (product code: LJS). This means it has been determined *substantially equivalent* to a legally marketed device, ensuring it meets FDA safety and effectiveness requirements for its intended use as a long-term intravascular therapeutic catheter.
What storage and handling precautions should be taken with the Groshong NXT PICC Catheter?
The catheter must be stored and handled according to standard sterile medical device protocols, as it is supplied sterile. This includes maintaining sterile packaging until use, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions to preserve sterility and functionality.
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: Bard Groshong NXT PICC Instructions For Use Manual, Bard Groshong NXT PICC Manuals | ManualsLib, Bard Groshong NXT PICC Manual | AI Chat & PDF Access | Manualzz, Groshong® PICC catheter | BD, PDF K3O 2- -0 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201452 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K201452 24 fields · synced Sep 19, 2026