Atlas FDA

STRYKER PAINPUMP2

FDA 510(k) clearance K030661 · decided 2003-05-30

Clearance details

K-number
K030661
Device name
STRYKER PAINPUMP2
Applicant
Stryker Instruments
Decision
Substantially Equivalent
Date received
2003-03-03
Decision date
2003-05-30
Days to decision
88 days
Clearance type
Traditional
Product code
MEA
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256)Hospira, Inc.2004-12-06
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Recalls involving this device

RecordFirmDate
Stryker Sheath 17 gage 12 inch for use with Stryker Pain Pump, REF 540-428, Rx, Sterile, P recall (Z-2357-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile, Pr recall (Z-2358-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile, Pr recall (Z-2359-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03