Atlas FDA

SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL

FDA 510(k) clearance K042359 · decided 2004-11-17

Clearance details

K-number
K042359
Device name
SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
Applicant
Medical Designs, LLC
Decision
Substantially Equivalent
Date received
2004-08-31
Decision date
2004-11-17
Days to decision
78 days
Clearance type
Traditional
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Sioux Falls, SD, US
Third-party review
No
Expedited review
No

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Recalls involving this device

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Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (C recall (Z-0551-2014)Integra LifeSciences Corp. d.b.a. Integra Pain Management2013-12-20