Atlas FDA

PERIFUSE CATHETER

FDA 510(k) clearance K121525 · decided 2012-08-02

Clearance details

K-number
K121525
Device name
PERIFUSE CATHETER
Applicant
Smiths Medical Asd, Inc.
Decision
Substantially Equivalent
Date received
2012-05-23
Decision date
2012-08-02
Days to decision
71 days
Clearance type
Traditional
Product code
CAZ
Device class
2
Regulation number
868.5140
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

No recalls on record reference this clearance.

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