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The Pressure Injectable M/29TM is a Peripherally Inserted Catheter Device which is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling and pressure injection applications such as contrast media injection. The maximum flow rate for Flexicath Pressure Injectable midline catheter may not exceed 5ml/sec.

Flexicath's M/29™ Pressure Injectable device is actually the very same device cleared under K080793 (FirmGrip - Peripherally Inserted Catheter) and K092629 (same device with the addition of the Safety Needle Mechanism (SNM). It is also similar to Arrow's Pressure Injectable PICC and has the very same claim (use with pressure injection of up to 300psi or 5ml/sec flow rate). Other aspects of Arrow's device are not relevant to our M/29 catheter (such as: antimicrobial claim; being used as PICC and; time duration exceeding 29 days). The main addition in Flexicath M/29 Catheter within this submission is to allow high pressure applications at up to 300psi or 5ml/sec flow rate. No redesign of M/29 catheter or engineering modifications took place in order to comply with this pressure and flow rate definition. The components' list and materials remain the same as in Flexicath's predicate devices indicated above. The mode of operation of Flexicath's M/29 also remain the same but with the addition of meeting the pressure injection claim for up to 300psi or 5ml/sec. The indication for use was revised in order to reflect the additional claim for pressure injection. Several minor other modification (not relevant to the pressure injection), are presented in our submission. The changes are: - a) A color change of the friction unit: from natural to pink colorant in order to make it more visible. - b) A 10cm length catheter unit assembly was added in addition to the current length exists. - c) The single unit package was changed from a pouch to a hard (rigid) blister. - d) A luer cap was added separately within the blister package as an accessory to close the catheter's female luer connection when open.

The SNM FirmGrip™ - Peripherally Inserted Catheter Device is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling.

Flexicath's SNM FirmGrip™ is actually the same device cleared under K080793 except for the addition of Safety Needle Mechanism (SNM) to the Cleared Needle Unit Assemblv. The Safety Needle Mechanism is a unique feature enables needle retraction into a tubular housing once it is taken out from the patient vein. Once the needle is withdrawn from the vein, the safety mechanism is activated by a simple press on the safety mechanism Activation Button (Locking Clip). The SNM has a male connector which is used to be inserted into the FirmGrip™ PeelGuard's female connector when being integrated with the FirmGrip™ Catheter and Catheter Sleeve at the Catheter insertion stage. The compressed spring is being restrained by a Locking clip which used to hold it in place until safety mechanism is activated. Once the Locking clip button is pushed, the SNM is being activated and the needle is being retracted and fully covered. At this stage the FirmGrip Needle Unit Assembly and the SNM are ready to be disposed.

The FirmGrip 101 Peripherally Inserted Catheter Device is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling.

The FirmGrip™ peripherally inserted catheter includes a typical midline catheter encapsulated in a specially designed protective sleeve, to produce a self-contained clean catheter insertion field. The catheter contains a stiffening guidewire for additional contribution to ease of insertion and for catheter's internal air volume reduction. Both the catheter and guidewire remain protected throughout the entire catheter insertion procedure and is not exposed to the outer environment or to any hand contact. The protective sleeve back side is closed with a Tortuous Path Disc (TP Disc) which closed it and provides additional protection. Being the catheter protected by the sleeve, may save the need of using a sterile sheet since the sleeve may replace it. The protective sleeve enables manipulation and insertion of the catheter without interfering the protective sleeve's internal clean field. Once the catheter is properly placed in the blood vessel, both protective sleeve and the guidewire are removed and discarded. The FirmGrip™ is packed in an individual sterile pack and is sterilized by EtO. A needle assembly unit contains a specially designed adapter, called "PeelGuard", and a PeelAway needle introducer is supplied with the FirmGrip or separately. The needle assembly unit has its own individual package and is sterilized by EtO as well. The operation mechanism for the modified device is the same as the original device. The protective sleeve's handgrip portion, in its front side, has an accordion-shape which helps to promote the catheter with each intermittent grasping and pushing it forward. Once both the sleeve and the wire are removed, the catheter remains inside the vein. The catheter luer connector and a short portion of the catheter remain outside of the body and used as an access port for the medical treatment. The soft materials used for the catheter and PeelGuard make the connections more flexible, easy to use for the medical staff and more convenient for the patient.

The FirmGrip " Peripherally Inserted Catheter device is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling.

The FirmGrip™ peripherally inserted catheter includes a standard catheter encapsulated in a specially designed protective sleeve. The protective sleeve enables manipulation, handling, and insertion of the catheter . The catheter component is a standard, legally marketed catheter. The FirmGrin™ peripherally inserted catheter contains color coded hubs, one cm markings for easier length determination, and is fully radio-opaque. The catheter is incorporated into the FirmGrip™ sterile protective sleeve. A specially designed adapter, called the PeelGuard, and a Peel Away Needle Introducer are supplied with the Firm Grip The device. The FirmGrip™ protective sleeve comprises a long sheath with a special handgrip and a friction unit at the tip. The handgrip portion is located near the tip of the protective sleeve. The special handgrip is shaped like an accordion and moves back automatically in an accordion-like motion to facilitate the catheter insertion. The catheter is advanced slowly by grasping the catheter through the handgrip portion of the FirmGrip™ protective sleeve and pushing it forward. Pressure is released to allow the accordion-like motion of the protective sleeve to return the handgrip portion to its original position. The catheter is continuously advanced as described above until the catheter is completely in place. The long sheath portion of the protective sleeve contains the catheter and is designed to accommodate the length of a midline catheter. The tip of the catheter is located within the tip of the protective sleeve and the remainder of the catheter lies within the long sheath portion. The tip of the protective sleeve contains butterfly wings for ease of use, holding and securing the catheter in place. The tip of the protective sleeve is closed with a luer cap until use. When ready for use, the luer cap is removed and the specially designed adapter, called the PeelGuard is attached to the tip of the protective sleeve. The tip of the protective sleeve connects to the peel-away needle introducer via the PeelGuard adapter. Upon placement of the catheter within the vein, the remainder of the catheter may be removed from the protective sleeve by pulling back on the hand grip of the protective sleeve. The final device is packaged in a blister pack and sterilized by EtO Sterilization