Atlas FDA

TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT

FDA 510(k) clearance K061573 · decided 2006-09-19

Clearance details

K-number
K061573
Device name
TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
Applicant
Hospira, Inc.
Decision
Substantially Equivalent
Date received
2006-06-07
Decision date
2006-09-19
Days to decision
104 days
Clearance type
Special
Product code
DRS
Device class
2
Regulation number
870.2850
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Lake Forest, IL, US
Third-party review
No
Expedited review
No

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Compass Cast and MAP (K161408)Centurion Medical Products Corporation2016-11-22
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Flo Trac sensor, Volume View sensor (K152980)Edwards Lifesciences, LLC2016-01-19
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COMPASS CT, COMPASS CT PORT (K133624)Mirador Biomedical2014-04-18
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Recalls involving this device

RecordFirmDate
4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS The Transpac Dispo recall (Z-0414-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. recall (Z-0415-2017)ICU Medical, Inc.2016-11-15
Transpac IV Bifurcated Monitoring Kit 48", 2 Disposable Transducers, 2 03 ml Intraflo Flus recall (Z-0416-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. recall (Z-0417-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT WITH 2 BONDED STOPCOCKS, 72", DISPOSABLE TRANSDUCER WITH 2 BOND recall (Z-0418-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac Disposabl recall (Z-0419-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV BIFURCATED KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORTS, 84" TUBING, 2 recall (Z-0420-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 recall (Z-0421-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV DISPOSABLE TRANSDUCER, Item No. 42582-05 The Transpac Disposable Straight Pres recall (Z-0422-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42582-06 The Transpac Disposabl recall (Z-0423-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK, Item No. 42582- recall (Z-0424-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3mL SQUEEZE FLUS recall (Z-0425-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (INTENDED recall (Z-0426-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush Device, Macrodr recall (Z-0427-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE FLUSH, recall (Z-0428-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Ite recall (Z-0429-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFU recall (Z-0430-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP (PO recall (Z-0431-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO FLUS recall (Z-0432-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP (PAT recall (Z-0433-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE F recall (Z-0434-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 recall (Z-0435-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure Tubi recall (Z-0436-2017)ICU Medical, Inc.2016-11-15
Transpac IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure Tubi recall (Z-0437-2017)ICU Medical, Inc.2016-11-15
Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 42598-01 The Tran recall (Z-0438-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH AND MACRODRIP ( recall (Z-0439-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MICRODRIP (POL recall (Z-0440-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT , 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MICRODRIP (P recall (Z-0441-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT WITH 2 SAFESET" BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TR recall (Z-0442-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POL recall (Z-0443-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, DISPOSABLE TRANSDUCER, 30 ML SQUEEZ recall (Z-0444-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DI recall (Z-0445-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DI recall (Z-0446-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DI recall (Z-0447-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DI recall (Z-0448-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISP recall (Z-0449-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO FL recall (Z-0450-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, recall (Z-0451-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCERS, 2 3 ML SQUEEZE FL recall (Z-0452-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS, recall (Z-0453-2017)ICU Medical, Inc.2016-11-15
TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, Item No. 42664-01NS T recall (Z-0454-2017)ICU Medical, Inc.2016-11-15
Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 The Transpac recall (Z-0455-2017)ICU Medical, Inc.2016-11-15
SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. 46047-17 The recall (Z-0456-2017)ICU Medical, Inc.2016-11-15
CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19 The Transpac Disposable Straight recall (Z-0457-2017)ICU Medical, Inc.2016-11-15
ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 The Transpac Di recall (Z-0458-2017)ICU Medical, Inc.2016-11-15
MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 The Transpac recall (Z-0459-2017)ICU Medical, Inc.2016-11-15
CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18 The Transpac Disposable S recall (Z-0460-2017)ICU Medical, Inc.2016-11-15
ART/CVP KIT W/03ML FLUSH DEVICE FOR MILWAUKEE CHILDRENS HOSP., Item No. 46059-28 The Trans recall (Z-0461-2017)ICU Medical, Inc.2016-11-15
KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Disposable Strai recall (Z-0462-2017)ICU Medical, Inc.2016-11-15
DOUBLE LINE KIT WITH 03ML FLUSH DEVICE FOR UNIVERSITY OF MICHIGAN HOSP., Item No. 46063-03 recall (Z-0463-2017)ICU Medical, Inc.2016-11-15

PMA approvals by this applicant

RecordFirmDate
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S008)Hospira, Inc.1999-01-29
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S007)Hospira, Inc.1996-09-05
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S006)Hospira, Inc.1996-01-04
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S003)Hospira, Inc.1995-12-15
DEXTRAN HM 32 (P880028/S002)Hospira, Inc.1990-11-15
DEXTRAN HM 32 (P880028/S001)Hospira, Inc.1989-12-29
DEXTRAN HM 32% (P880028)Hospira, Inc.1989-05-30