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Found 18 results
510(k) Data Aggregation
K Number
K141285Device Name
BUSSE EXTENSION SET
Manufacturer
BUSSE HOSPITAL DISPOSABLES
Date Cleared
2015-02-19
(279 days)
Product Code
FPA, FPK
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BUSSE HOSPITAL DISPOSABLES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Busse Extension Sets are intended to be used with a vascular access device for administrative and withdrawals of fluids.
Device Description
Busse Extension Set consists of PVC tubing with or without connectors. The tubing accessories include; 3-way connectors, clamps, male and female luer lock, luer slip fitting, and valves. The Extension Set will be provided as sterile, single use only and will be packaged individually and in medical convenience kits. The Extension Sets will be available in a variety of lengths, starting from 6" to 36".
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K Number
K120002Device Name
I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
Manufacturer
BUSSE HOSPITAL DISPOSABLES, INC.
Date Cleared
2012-06-26
(175 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
BUSSE HOSPITAL DISPOSABLES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The I-Style Bone Marrow Aspiration Needle with T-Handle is intended for aspiration of bone marrow.
Device Description
The I-Style Bone Marrow Aspiration Needle with T-Handle consists of a 15G and 18G needle with a triple sharpened atraumatic tip stylet of corresponding size all made of AISI 304 Stainless steel. The needle has an ergonomic grip at whose base a Luer-Lock cone in fitted. The innovative element of the needle is a removable spacer, which indicates the depths the tip can reach. Using a depth stopper, easy adjustment of the needle length, making it easier to reach the tissue to be examined.
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K Number
K110883Device Name
J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA
Manufacturer
BUSSE HOSPITAL DISPOSABLES
Date Cleared
2011-06-08
(70 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
BUSSE HOSPITAL DISPOSABLES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Biopsy Instrument is used for drawing of osteomedullary substance or for explantation of bone marrow with a Snare-It Acquisition Cannula intended to contain the specimen during withdrawal from the needle's cannula.
Device Description
The J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula consists of a J-style Bone Marrow Biopsy / Aspiration Needle with cap, providing the physician with greater torque than similar instruments, an ABS Ergonomic grip handle, which increases accuracy and speeds biopsy operation. It comes in 3 sizes; 8G x 4", 11G X 4", and 13G x 4". A Stylet, consisting of a locking mechanism to secure position in Biopsy needle, as well as a stainless steel cannula with a trocar tip for easier penetration into bone tissue. The Snare-it Marrow Acquisition Cannula is designed to allow the tissue to remain intact during removal. This allows for accurate analysis. It also allows additional sample collection without having to re-insert needle into the patient. A stainless steel, sample extractor, allows for convenient sample removal from the cannula. And finally, an extractor Cap.
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K Number
K093920Device Name
BUSSE EPIDURAL CATHETER KIT
Manufacturer
BUSSE HOSPITAL DISPOSABLES
Date Cleared
2010-08-06
(227 days)
Product Code
BSO
Regulation Number
868.5120Why did this record match?
Applicant Name (Manufacturer) :
BUSSE HOSPITAL DISPOSABLES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The epidural catheter is intended for administration of local anesthetics into epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.
Device Description
The Epidural Catheter kit consists of clear tubing with a black radiopaque stripe, a Thread assist guide, a Connector Gasket, and a Tuohy Borst adapter catheter connection. All inserted in a Polvethylene bag. The catheter is marked at 5 cm from the tip with 1 cm increments up to 20 cm. The 10 cm mark is indicated by two marks, the 15 cm by three marks, and the 20 cm by four marks. The Catheter will be available 20 Gauge, with a nominal length of 36 inches. It will be available in open tip or closed tip with 3 eyes. As an extra safety feature, the tip of the catheter is incorporated with a marking to assure the completed catheter has been removed.
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K Number
K093909Device Name
BUSSE SURGICAL DRAPES IV
Manufacturer
BUSSE HOSPITAL DISPOSABLES, INC.
Date Cleared
2010-05-06
(135 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
BUSSE HOSPITAL DISPOSABLES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Busse Surgical Drape IV is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide.
Device Description
Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.
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K Number
K092212Device Name
BUSSE SURGICAL DRAPES III
Manufacturer
BUSSE HOSPITAL DISPOSABLES, INC.
Date Cleared
2009-10-09
(79 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
BUSSE HOSPITAL DISPOSABLES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Busse Surgical Drape is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide. This is the same intended use as a previously cleared for the Busse Surgical Drape II, K083424.
Device Description
The Laminated Non-Woven Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.
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K Number
K082297Device Name
BUSSE SURGICAL DRAPE
Manufacturer
BUSSE HOSPITAL DISPOSABLES, INC.
Date Cleared
2008-12-09
(119 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
BUSSE HOSPITAL DISPOSABLES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Busse Surgical Drape is intended for external use only and is used is as a protective patient covering, such as to isolate a site of surgical incisions from it a vacu is a a provided steries using ethylene oxide.
Device Description
Surgical drapes are intended to provide protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.
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K Number
K073222Device Name
MODIFICATION TO:SPECIALTY NEEDLES
Manufacturer
BUSSE HOSPITAL DISPOSABLES, INC.
Date Cleared
2008-04-09
(146 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
BUSSE HOSPITAL DISPOSABLES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
specialty needles - Spinal Needle, Pencil Point Needle, and Epidural Needle - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
Device Description
Anesthesia conduction needles consist of different styles. All the needles consist of a plastic or K-Resin hub connected to a stainless steel cannula. Some of the needles have stylets made of the same steel whereas others have stylets made of plastic. Some of the needles have wings, which can be attached to the hub for more stability depending on user procedure. The needles have been categorized as following: 1. Spinal Needles (Quincke) 2. Pencil Point Spinal Needle (Whitacre) 3. Epidural Needles (Tuohy & Hustead) The differences between the styles of needles are the tip of the needle, which is pencilpoint-tip (Whitacre), curved and sharp needle (Toulty) or sharp needle tin (Quincke)
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K Number
K070465Device Name
BUSSE EPIDURAL CATHETER
Manufacturer
BUSSE HOSPITAL DISPOSABLES, INC.
Date Cleared
2007-07-19
(153 days)
Product Code
BSO
Regulation Number
868.5120Why did this record match?
Applicant Name (Manufacturer) :
BUSSE HOSPITAL DISPOSABLES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Epidural Catheter is intended for administration of local anesthetics into the epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.
Device Description
The Busse Epidural Catheter is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The Catheter will also be sold as a non-sterile product to kit packers, who then may sterilize the catheter as part of a kit.
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K Number
K063018Device Name
GLASS LOSS OF RESISTANCE SYRINGE
Manufacturer
BUSSE HOSPITAL DISPOSABLES, INC.
Date Cleared
2007-01-22
(112 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Applicant Name (Manufacturer) :
BUSSE HOSPITAL DISPOSABLES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glass Loss of Resistance Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique; it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The Syringe will be sold sterile individually packaged, and as part of a sterile kit.
Device Description
The Glass Loss of Resistance Syringe is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The syringe will be available in luer lock and luer slip tip.
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