(90 days)
- The MEDIMEX Epistar CSE kit is intended for administration of epidural anesthesia that may be combined with a spinal aneshetic. The MEDIMEX Epistar CSE kit I is intended for single epidural infections for use enidural ansthesia, for of the MEDIMEX catherer in the CSE kit for continuous epidural needle is also inten of the MEDIMEX catheter in the CSE Kit for continuous condum and our and on allow catheterization duration of up to 72 hours. The CSE epidural needle is also intended to allo catheterization duration of up to 72 nouts. The CSL cpace to provide anesthesia passage of a pencil point-spinal needle into the intratesal space to provide anesthesia passage of a pencil point-spinal needle into intrallect. The MEDIMEX Epistar immediately before or after placement of the epidural parties only to provi immediately before or atter placement of the epiddral needle, is intended only to provide epidural kit containing the conventional epistar epidural space for epidural kit containing the conventional epistal epistal collection of the epidural space for up to 72 hours.
- Prescription use
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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA letter regarding a 510(k) notification for a medical device (MEDIMEX Epistar/Epistar CSE Spinal/Epidural Anesthesia Kits). It mentions the device's intended use but does not include any details about acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical study report.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).