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510(k) Data Aggregation
K Number
K191290Device Name
Ancora Nerve Block Catheter Set
Manufacturer
Date Cleared
2020-02-06
(269 days)
Product Code
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
Ancora Medical Technology
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ancora Nerve Block Catheter Set is indicated for surgical pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The device allows physicians to locate peripheral nerves by transferring electrical impulses from a nerve stimulator and/or through ultrasound visualization of the device. The catheter may remain in dwelling for up to 72 hours.
Device Description
The Ancora Nerve Block Catheter Set is a sterile, single-use, disposable device, intended for delivery of local anesthetic for continuous peripheral nerve blocks, in adult patients. The Ancora Nerve Block Catheter Set is intended to be placed with the use of nerve stimulation and/or ultrasound guidance. The device has a catheter-over-needle design, which consists of a 21-gauge needle and 18-gauge catheter with a twist lock connection between them. The device design includes an anchor and decoupler to help maintain the catheter position. Both the needle and catheter have NRFit connection for infusion. The device set includes two sizes of dressings.
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