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picc wand peelable safety introducer
Access Scientific
Summary: The PICC Wand Peelable Safety Introducer is a medical device used for the insertion of peripherally inserted central catheters (PICC lines). It is primarily used by interventional radiologists and vascular access specialists to facilitate safe and efficient catheter placement.
FDA Clearance Information
Pathway
510K
Number
K101150 ↗
Decision Date
August 13, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The PICC Wand Peelable Safety Introducer was cleared through the FDA 510(k) pathway on August 13, 2010. Manufactured by Access Scientific, this device is classified as a Class 2 medical device under product code DYB.
What It Is
The PICC Wand Peelable Safety Introducer is designed to aid in the insertion of PICC lines by providing a peelable sheath that simplifies the process. It integrates a safety mechanism to minimize the risk of needle-stick injuries, enhancing safety for both patients and healthcare providers. The device is particularly useful in settings where central venous access is required for long-term intravenous therapy.
Clinical Applications
This device is commonly used in hospitals and outpatient settings for patients requiring long-term intravenous access, such as those undergoing chemotherapy, extended antibiotic therapy, or total parenteral nutrition. It is frequently utilized by interventional radiologists, vascular access teams, and specialized nursing staff. The device is suitable for adult and pediatric patients who need reliable venous access.
Indications for Use
The FDA indications for the PICC Wand Peelable Safety Introducer include its use in the insertion of PICC lines. It is indicated for patients who require central venous access for extended periods, such as those receiving long-term medication or nutrition intravenously.
Practical Considerations
The PICC Wand is available in various sizes to accommodate different patient anatomies and catheter specifications. It is compatible with most standard PICC lines and requires familiarity with sterile technique and ultrasound guidance for optimal placement. Clinicians should be trained in the use of peelable introducers to ensure safe and effective use.
Frequently Asked Questions
What is the PICC Wand Peelable Safety Introducer used for?
It is used for the insertion of peripherally inserted central catheters (PICC lines) to provide long-term intravenous access.
What specialties typically use this device?
Interventional radiologists, vascular access specialists, and specialized nursing staff commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the insertion of PICC lines in patients requiring long-term central venous access.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.