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510(k) Data Aggregation
K Number
K121748Device Name
THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL
Manufacturer
ACCESS SCIENTIFIC, INC.
Date Cleared
2012-07-27
(43 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ACCESS SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The POWERWAND® Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5 ml/sec at up to 300 psi fluid pressure.
Device Description
The POWERWAND® Safety Introducer with an Extended Dwell Catheter is an all-in-one preassembled intravascular catheter introducer with intravascular catheter that consists of the following basic components: Introducer Needle, Guidewire, Dilator and an Extended Dwell Catheter. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The Extended Dwell Catheter allows for withdrawal of blood and the administration of fluids, including power injection of contrast media. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.
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K Number
K111417Device Name
THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
Manufacturer
ACCESS SCIENTIFIC, INC.
Date Cleared
2011-07-15
(56 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ACCESS SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The POWERWAND® Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5cc/sec at up to 300 psi fluid pressure.
Device Description
The POWERWAND® Safety Introducer with an Extended Dwell Catheter is an all-in-one preassembled intravascular catheter introducer with intravascular catheter that consists of the following basic components: Introducer Needle, Nitinol Guidewire. Dilator and an Extended Dwell Catheter. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place the in-dwelling intravascular catheter through the skin into the circulatory system. The Extended Dwell Catheter allows for withdrawal of blood and the administration of fluids, including power injection of contrast media. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.
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K Number
K111138Device Name
THE PICC WAND (R) PEELABLE SAFETY INTRODUCER
Manufacturer
ACCESS SCIENTIFIC, INC.
Date Cleared
2011-06-22
(61 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ACCESS SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
Device Description
The PICC WAND® Peelable Safety Introducer is an all-in-one preassembled intravascular catheter introducer that consists of the following basic introducer components: Introducer Needle, Nitinol Guidewire. Dilator and a peelable Sheath Introducer. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The peelable Sheath Introducer allows for the placement of peripherally inserted central catheters (PICC) and midline catheters. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.
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K Number
K101422Device Name
THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
Manufacturer
ACCESS SCIENTIFIC, INC.
Date Cleared
2011-03-22
(306 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ACCESS SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Power WAND™ Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5cc/sec at up to 300 psi fluid pressure.
Device Description
The Power WAND™ Safety Introducer with an Extended Dwell Catheter is an all-in-one pre-assembled device that combines the functionality of a catheter introducer system with an extended dwcll (> 72 hours but < 30 days) intravenous (IV) Catheter. The Power WAND™ Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to insert the IV Catheter. The IV Catheter may then be left in place for a period of < 30 days and used to sample blood and administer fluids intravenously. It can also be used to power inject contrast media up to a rate of 5 cc/sec. at a maximum of 300 psi fluid pressure.
The Power WAND™ Safety Introducer with an Extended Dwell Catheter is provided "STERILE" by cthylene oxide gas and is labeled "Nonpyrogenic" and for "Single-Use".
The device is composed of the following components:
- Needle
- Guidewire
- Dilator
- Extended Dwell IV Catheter
The Power WAND™ Safety Introducer with an Extended Dwell Catheter accesses the target vessel using the Accelerated Scldinger Technique (AST). Once the IV Catheter is positioned within the target circulatory vessel the Needle/Guidewire/Dilator are removed from the patient as a single unit. The remaining indwelling single-lumen IV Catheter is used to sample blood and administer fluids intravenously for a time period of < 30 days. It can also be used to power inject contrast media up to a rate of 5 cc/sec at a maximum fluid pressure of 300 psi. A catheter stabilization device, Statl.ock IV Ultra®, is provided as an accessory to securely anchor the IV Catheter in place during use.
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K Number
K101150Device Name
PICC WAND PEELABLE SAFETY INTRODUCER
Manufacturer
ACCESS SCIENTIFIC, INC.
Date Cleared
2010-08-13
(112 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ACCESS SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PICC WAND™ Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
Device Description
The PICC WAND™ Peelable Safety Introducer is an all-in-one preassembled intravascular catheter introducer that consists of the following basic introducer components: Introducer Needle, Nitinol Guidewire, Dilator and a peelable Sheath Introducer. It is intended to provide the clinician with a safe, simple and accelerated approach, using the Accelerated Seldinger Technique, to place an in-dwelling intravascular catheter through the skin into the circulatory system. The peelable Sheath Introducer allows for the placement of peripherally inserted central catheters (PICC) and midline catheters. The device includes a Fast-flash™ feature that provides the clinician with feedback that the introducer needle is in the intraluminal position within the blood vessel. The device also incorporates a safety mechanism to guard against accidental needle stick.
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K Number
K093022Device Name
THE PICC WAND PEELABLE SAFETY INTRODUCER
Manufacturer
ACCESS SCIENTIFIC, INC.
Date Cleared
2010-01-20
(113 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ACCESS SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
Device Description
The PICC WAND® Peelable Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and a Peelable Sheath Introducer in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
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K Number
K090372Device Name
THE WAND MICROACCESS SAFETY INTRODUCER
Manufacturer
ACCESS SCIENTIFIC, INC.
Date Cleared
2009-03-30
(45 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ACCESS SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
Device Description
The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
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K Number
K081697Device Name
THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006
Manufacturer
ACCESS SCIENTIFIC, INC.
Date Cleared
2008-12-04
(170 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
ACCESS SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the peripheral circulatory system.
Device Description
The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
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