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Codman & Shurtleff, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories5
Latest FDA decision2020-07-20
TypeNumberDevice NameCodeDateActions
510(k) K193380 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetNRY2020-07-20 View
510(k) K191237 CERENOVUS Large Bore CatheterDQY2019-11-08 View
510(k) K173192 CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitGWM2017-11-08 View
510(k) K172537 Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagJXG2017-10-16 View
510(k) K172022 CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)JXG2017-10-03 View
510(k) K171862 GALAXY G3 Mini Microcoil Delivery SystemHCG2017-09-25 View
510(k) K171747 MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery SystemHCG2017-07-14 View
510(k) K171653 YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpDQY2017-07-03 View
510(k) K162563 YOGA MicrocatheterDQY2017-01-05 View
510(k) K162437 Codman EDS3 CSF External Drainage SystemJXG2016-10-28 View
510(k) K153347 Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter KitGWM2016-08-19 View
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