Atlas FDA

MEDTRONIC PS MEDICAL STRATA TYPE VALUE

FDA 510(k) clearance K060681 · decided 2006-09-15

Clearance details

K-number
K060681
Device name
MEDTRONIC PS MEDICAL STRATA TYPE VALUE
Applicant
Medtronic Neurosurgery
Decision
Substantially Equivalent
Date received
2006-03-15
Decision date
2006-09-15
Days to decision
184 days
Clearance type
Special
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Goleta, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medtronic Neurosurgery

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) (K261004)Integra Lifesciences Production Corporation2026-06-23
Intellidrop (K251598)Brainspace, Inc.2025-12-10
Sophy Mini Monopressure Valve (SM1) (K250636)Sophysa2025-11-28
EVAC-MRI (K252514)Phasor Health, LLC2025-11-05
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (K243531)Integra Lifesciences Production Corporation2025-08-08
Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) (K243552)Integra Lifesciences Production Corporation2025-08-06
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters (K242974)Sophysa2025-06-20
EVAC (K243205)Phasor Health, LLC2025-06-03
Duet External Drainage and Monitoring System (EDMS) (K243676)Medtronic Neurosurgery2025-03-10
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (K242003)Aesculap, Inc.2024-12-16
Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (K241458)Borvo Medical, Inc.2024-08-20
Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter (K233445)Integra Lifesciences Production Corporation2024-01-17

Recalls involving this device

RecordFirmDate
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Cat recall (Z-1121-2017)Medtronic Neurosurgery2017-02-02