Atlas FDA

PORTEX EPIDURAL CATHETER

FDA 510(k) clearance K062005 · decided 2006-10-18

Clearance details

K-number
K062005
Device name
PORTEX EPIDURAL CATHETER
Applicant
Smiths Medical Asd, Inc.
Decision
Substantially Equivalent
Date received
2006-07-17
Decision date
2006-10-18
Days to decision
93 days
Clearance type
Special
Product code
BSO
Device class
2
Regulation number
868.5120
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Keene, NH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Portex Continuous Epidural Tray, Reference 4037-20 An anesthesia conduction kit is a devic recall (Z-2050-2009)Smiths Medical ASD, Inc.2009-09-03

PMA approvals by this applicant

RecordFirmDate
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018)Smiths Medical Asd, Inc.2013-05-13
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017)Smiths Medical Asd, Inc.2010-04-21
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016)Smiths Medical Asd, Inc.2009-04-20
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015)Smiths Medical Asd, Inc.2007-11-06
PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014)Smiths Medical Asd, Inc.2007-08-28
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013)Smiths Medical Asd, Inc.2007-04-05
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012)Smiths Medical Asd, Inc.2002-12-17
PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011)Smiths Medical Asd, Inc.2002-10-03