Solo PICC/Midline Catheter Kit Models 71924, 71908
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K961155 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 Solo PICC/Midline Catheter Kit Models 71924 and 71908 are intravascular catheters designed for long-term use (greater than 30 days). These devices are intended for peripheral intravenous access, including peripherally inserted central catheters (PICC) and midline catheters, facilitating fluid administration, medication delivery, and venous access in clinical settings.
The kits are supplied sterile, adhering to AAMI guidelines, and are intended for single-use. They are classified as Class II devices under FDA regulations and have received 510(k) clearance (K961155) for use in general hospital settings. Each model includes specific catheter sizes and components for insertion and securement, with no noted MRI compatibility restrictions. Storage follows standard sterile medical device protocols.
Frequently asked questions
Are these catheters suitable for patients who require long-term intravenous access, and if so, how long can they be used safely?
Yes, the Solo PICC/Midline Catheter Kits (Models 71924 and 71908) are explicitly designed for long-term use, defined as greater than 30 days. They are intended for peripheral intravenous access, including peripherally inserted central catheters (PICC) and midline catheters, making them suitable for extended fluid administration, medication delivery, and venous access in clinical settings.
How are these catheter kits supplied, and what should I consider regarding sterility and single-use?
The Solo PICC/Midline Catheter Kits are supplied sterile, adhering to AAMI (Association for the Advancement of Medical Instrumentation) guidelines. Each kit is intended for single-use only, meaning they should not be reused after one patient application to maintain sterility and safety.
What storage instructions should I follow for these catheter kits to ensure they remain effective?
The kits should be stored following standard sterile medical device protocols. Since they are sterile upon packaging, they must remain unopened and protected from contamination until use. Avoid exposure to extreme temperatures, moisture, or direct sunlight, and adhere to the manufacturer’s expiration date.
Are there any restrictions on using these catheters in patients who require MRI scans?
The Solo PICC/Midline Catheter Kits do not have any noted MRI compatibility restrictions in the provided data. However, it’s always recommended to verify compatibility with the specific MRI machine and settings, as materials can vary, and safety depends on the facility’s protocols.
What regulatory pathway was followed for FDA clearance of these catheters, and where can I find more details?
The Solo PICC/Midline Catheter Kits received FDA 510(k) clearance (K961155) under the traditional review pathway, classified as Class II devices. They were determined to be substantially equivalent to a predicate device and are intended for use in general hospital settings. For further details, you can reference the FDA’s openFDA database using the clearance number or registration numbers provided.
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: Solo Picc/Midline Catheter Kit Models 71924, 71908, Solo Picc/Midline Catheter Kit Models 71924, 71908, K961155 FDA 510(k) - SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, PDF K961155 - Solo Picc/Midline Catheter Kit Models 71924, 71908, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K961155 | Class II | Active |
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Manufacturer
- Manufacturer
- Douglas Medical Products Corp.
Sources (1)
- FDA 510(k) K961155 24 fields · synced Sep 19, 2026