Search Results
Found 4 results
510(k) Data Aggregation
K Number
K000977Device Name
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
Manufacturer
OLSON MEDICAL SALES, INC.
Date Cleared
2001-03-23
(361 days)
Product Code
DTR
Regulation Number
870.4240Why did this record match?
Applicant Name (Manufacturer) :
OLSON MEDICAL SALES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K993060Device Name
GAS FILTER
Manufacturer
OLSON MEDICAL SALES, INC.
Date Cleared
2000-03-28
(197 days)
Product Code
JOD
Regulation Number
870.4270Why did this record match?
Applicant Name (Manufacturer) :
OLSON MEDICAL SALES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gas Filter is intended to remove particulate matter from medical gases flowing into the cardiopulmonary bypass circuit for periods up to 6 hours.
Device Description
The proposed gas filter and the Gish filter are each made of materials that are commonly used in cardiopulmonary bypass devices and circuits. The Gish filter is made of ABS, and Versapor (Acrylic); the proposed devices are made of hydrophobic laminated glass media, Versapor (Acrylic) and polypropylene.
Ask a Question
K Number
K993062Device Name
CHEST DRAINAGE TUBING
Manufacturer
OLSON MEDICAL SALES, INC.
Date Cleared
1999-12-10
(88 days)
Product Code
DWE
Regulation Number
870.4390Why did this record match?
Applicant Name (Manufacturer) :
OLSON MEDICAL SALES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The chest drainage tubing is intended to serve as a conduit for the flow of body fluids that are removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures.
Device Description
The chest drainage tube is piece of flexible polyvinylchloride tubing that is used as a conduit for body fluids suctioned from the chest cavity and moved into a reservoir following cardiopulmonary bypass procedures. The tubing is a 40 durometer tube with an inside diameter of 0.375" and an outside diameter of 0.562".
Ask a Question
K Number
K992906Device Name
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
Manufacturer
OLSON MEDICAL SALES, INC.
Date Cleared
1999-11-10
(72 days)
Product Code
DTL
Regulation Number
870.4290Why did this record match?
Applicant Name (Manufacturer) :
OLSON MEDICAL SALES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.
Device Description
The adapters are used in connecting oxygenators, reservoirs, filters, tubing, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support.
The adapters are of the following generic types: straight adapters with or without luer locking mechanisms (male and female), large bore adapters, three-way connectors, and four-way connectors.
The materials used in the manufacturing of these adapters includes polycarbonate, acrylic, and Acrylonitrile-Butadiene-Styrene (ABS). The cleared Medtronics adapters are comprised of plexiglas and Note: polyvinyIchloride.
Ask a Question
Page 1 of 1