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510(k) Data Aggregation
K Number
K191470Device Name
C-CAT Anaesthesia Catheter kit
Manufacturer
Cimpax ApS
Date Cleared
2019-10-25
(144 days)
Product Code
BSO
Regulation Number
868.5120Why did this record match?
Applicant Name (Manufacturer) :
Cimpax ApS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CIMPAX C-CAT Anesthesia Catheter, along with related accessory devices, is intended for the delivery of continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.
Device Description
The CIMPAX® C-CAT catheter kit is a sterile, single use, closed tip, multi-perforated catheter with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. The kit is intended for adult patients requiring the delivery of contiguous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management or as perineural delivery. Routes of administration may be intraoperative or percutaneous. The device is intended to be used in healthcare /hospital facilities.
The CIMPAX® C-CAT catheter is a multi-perforated catheter supplied in a kit which contains components for catheter placement. The drug infusion segment is placed between the blue tip of the catheter and the first blue marking after the tip. The catheter is designed with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. Attached to the catheter is a standard female luer lock that is compatible with and can be used with infusion pumps as well as with syringes for bolus injections with standard make luer connections.
The catheter is placed usually through an incision or wound in order to provide continuous or intermittent administration of local anesthetic to the area affected. This allows only the local nerve endings (pain receptors) to be anesthetized as opposed to giving a systemic pain relief medication to the patient.
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