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510(k) Data Aggregation
K Number
K210047Device Name
Stiletto Extended Dwell Catheter
Manufacturer
Piper Access, LLC
Date Cleared
2021-08-27
(231 days)
Product Code
PND
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Piper Access, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use (<28 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Stiletto Extended Dwell Catheter is suitable for use with power injectors.
Device Description
The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or administer fluids over a short duration (<28 days) through a peripherally inserted catheter. The Stiletto EDC utilizes an introducer needle and sheathing cannula to support advancement of a single lumen, power-injectable, catheter into peripheral vasculature. Unique catheter tip geometry is employed that works in conjunction with a sheathing cannula to provide support as the catheter advances into the vessel, providing a reliable method of insertion without need of a guidewire. The catheter, hub and insertion components are integrated into a single housing to enhance ease of use.
The Stiletto EDC will be available in 8 cm and 10 cm lengths with a 20 gauge catheter, and 10 cm and 12 cm lengths with an 18 gauge catheter.
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K Number
K191976Device Name
Piper GO-IO Intraosseous Infusion System
Manufacturer
Piper Access, LLC
Date Cleared
2019-11-13
(112 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Piper Access, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Piper GO-IO® Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
Device Description
The Piper GO-IO® Intraosseous Infusion System provides clinicians and emergency personnel with access to the intraosseous space for resuscitation and lifesaving fluid delivery for up to 24 hours. The Piper GO-IO® Intraosseous Infusion System consists of the following:
- a single use hypodermic needle (with needle safety cap), ●
- a powered or manual driver to assist with needle insertion, ●
- an extension set, and;
- an adhesive-backed securement dressing.
For insertions using the powered driver, the hypodermic needle hub that mates with a stylet connected to a drive adapter hub. The drive adapter hub includes a magnetic insert that attaches to the powered driver prior to needle insertion. The Piper GO-IO® Powered Driver is a hand-held, batterypowered device with a rechargeable lithium battery used to assist in the insertion of the subject device needle through the bone cortex. The assembly of the hypodermic needle and stylet with connected drive adapter hub is referred to as the needle set.
For insertions using the manual driver, the needle and the needle hub mate with a stylet in the same way as the needle set that is used with the powered driver, except the stylet is integrated into the handle of the manual driver instead of a drive adaptor hub (i.e. the manual driver needle assembly does not include a drive adapter hub).
The stylet was designed to include a passive safety feature to protect the placer from sharps injury. After the needle is inserted, the stylet is separated from the needle and needle hub. Upon separation of the stylet from the needle hub, the passive safety feature is released onto the stylet tip and can be safely discarded into a sharps container. Following needle insertion, the securement dressing can be applied to secure the needle hub to the skin. An extension set is available for access to the needle hub to support fluid exchange.
The subject device Piper GO-IO® Intraosseous Infusion System will be offered in needle set (for use with the powered driver) and manual driver needle kit configurations. Each kit configuration will include a securement dressing and an extension set.
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