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Request – Bactiseal Catheters & Accessories (K233445, with correspondence)
Request – Bactiseal Catheters & Accessories (K233445, with correspondence)
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510(K) Number: K233445
Device Name: Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
Manufacturer: Integra LifeSciences Production Corporation
Device Classification Name: Shunt, Central Nervous System And Components
Regulation Number: 882.5550
Classification Product Code: JXG
Date Received: 10/19/2023
Decision Date: 01/17/2024
Regulation Medical Specialty: Neurology
Request Contents: Bactiseal Catheters (K233445) Request for a copy of Bactiseal Catheters, Bactiseal Barium Striped Catheters, and Bactiseal Endoscopic Ventricular Catheter. Includes all correspondence.
Device Name: Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
Manufacturer: Integra LifeSciences Production Corporation
Device Classification Name: Shunt, Central Nervous System And Components
Regulation Number: 882.5550
Classification Product Code: JXG
Date Received: 10/19/2023
Decision Date: 01/17/2024
Regulation Medical Specialty: Neurology
Request Contents: Bactiseal Catheters (K233445) Request for a copy of Bactiseal Catheters, Bactiseal Barium Striped Catheters, and Bactiseal Endoscopic Ventricular Catheter. Includes all correspondence.
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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