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510(k) Data Aggregation
K Number
K122834Device Name
POLYSITE IMPLANTABLE INFUSION PORTS
Manufacturer
Date Cleared
2013-12-11
(450 days)
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
Perouse Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The POLYSITE implanable infusion Port is indicated for long term access to the central venous system and allows for repeated vascular access.
POLYSITE Implantable Infusion venous access ports are used to administer chemotherapy, antibiotics and antiviral drugs. They can also be used for parenteral nutrition, collection of blood samples and transfusion of blood products.
A non-coring needle must be used to access POLYSITE Implantable Infusion Ports.
Some references of POLYSITE Pressure Injectable Implantable Infusion Port-PI references) can be used for high pressure injection of contrast media during diagnosic studies. The maximum flow rate of power injector equipment used with the pressure injectable port may not exceed 5 ml/s.
For high pressure injection of contrast media, a high pressure needle must be used to access the POLYSITE Pressure Injectable implantable Infusion port. The manufacturer recommends the use of PPS PI Pressure Injectable Safety Huber needle.
Device Description
POLYSITE Implantable Infusion Port is composed of a radiopaque dome or housing and a self sealing septum, connected to a radiopaque catheter by a connecting ring (supplied unassembled). The port is accessed percutaneously by using a non-coring needle.
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K Number
K123035Device Name
SEAL ONE
Manufacturer
Date Cleared
2012-11-28
(61 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
Perouse Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SEAL ONE Radial compression Device is used for coronary angiography and angioplasty procedures practiced in a radial approach to compress the puncture site.
Device Description
The SEAL ONE® may be used on the right or left wrist. The device placement time should be set on the time indicator, which should subsequently be locked. Wrist strap is secured by a strap which is clipped. The wrist strap can be twisted in to shorten it. Compression is applied by turning the compression knob clockwise. Decompression is done by pressing simultaneously on the safety button and turning the compression knob anticlockwise. It is possible to write on the wrist strap with ballpoint pen or indelible felt pen, to indicate the times at which the device was checked and steps during decompression. The dedicated positions for this are shown by the following symbols at the ends of the wrist strap.
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K Number
K120261Device Name
PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER
Manufacturer
Date Cleared
2012-05-02
(96 days)
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Perouse Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PPS PI® curved safety Huber needle is indicated for:
- Administration or withdrawal of fluids through implanted ports.
- Pressure injection of contrast media into the central venous system only with an implantable infusion port that is also indicated for pressure injection.
-The maximum recommended infusion rate at 11,8 cPs is :
- 5mL/sec. for 19 Ga. needle
- 5 mL/sec. for 20 Ga. needle
- 2 mL/sec. for 22 Ga. needle.
- The PPS PI® Curved Safety Huber needle is indicated to PPS PI® Curved Safety Huber needle does not protect against other routes of blood-borne pathogen transmission.
Device Description
The PPS PI® Pressure Injectable Safety Huber Needle is a curved safety Huber needle mounted with one connection line ideal for accessing pressure injectable ports. This device allows pressure injection of contrast media during CT (computerized tomography) scans or MRI (computerized tomography) and is MR Conditional. The PPS PI® curved Huber needle is available in various lengths and diameters; with or without a lateral injection site. Luer-Lock connectors, are provided, on which closed protective caps are screwed (end of the main line and of the Y site) which must not be used as sealing caps. One clamp is also provided (2 clamps for references with "Y" site) PPS PI® Pressure Injectable Safety Huber Needle is single use
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