20G 8CM Stiletto Extended Dwell Catheter

FDA UDI

Class II (US FDA UDI)

by Avia Vascular

Identity

Trade Name: 20G 8CM Stiletto Extended Dwell Catheter FDA UDI
Generic Name: Peripheral intravenous cannula FDA UDI
Device Name: 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. FDA UDI
Model / Reference: PIP200000 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850042365052 FDA UDI
510(k) Number: K210047 FDA UDI
FDA Product Code: PND FDA UDI
GMDN Term: Peripheral intravenous cannula FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 1.1 Millimeter FDA UDI
Catheter Length — 80 Millimeter FDA UDI

Category: Peripheral intravenous cannula

20G 8CM Stiletto Extended Dwell Catheter by Avia Vascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Peripheral intravenous cannula.

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McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
Navilyst Medical — NAVILYST MEDICAL, INC.
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II

Cleared under the same submission

K210047 also covers:

20G 8CM Stiletto Extended Dwell Catheter — Slipstream Medical, LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Avia Vascular

Sources (1)

FDA UDI 6de8ccac-4df1-42c2-8ec2-b0de4b099dd8 36 fields · synced May 31, 2026