ClearanceBrief
Panels › Cardiovascular › Product code DRS · Class 2

Transducer, Blood-Pressure, Extravascular

Regulation 870.2850

1510(k)s in 12 months (149 all time)
2recalls in 12 months (236 all time)
226recalls that name a 510(k)
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Top companies in DRS

Company510(k)sRecalls
ICU Medical, Inc.0198
Smiths Medical Asd, Inc.218
Edwards Lifesciences, LLC37
Argon Medical Devices, Inc09
Medex, Inc.70
Sorensen Research70
Gould, Inc.60
Transamerica Delaval, Inc.60
Hewlett-Packard Co.50
Bentley Laboratories, Inc.40
DateFirm and productCodeLinked 510(k)
Nov 15, 2016ICU Medical, Inc.
Transpac IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Disposable Transducer w/Stopcocks w/o Cap and Covers, Item No. 46112-30NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interface
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Monitoring Kit w/Arterial 84" Safeset" Reservoir, 03 ml Squeeze Flush Device and Needleless Valves, Item No. 46112-13 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extr
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and Macrodrip, Item No. 46112-10 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravas
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Monitoring Kit w/Safeset" Blood Sampling Port and 03 ml Squeeze Flush Device 10 cc Sheathed Syringe, Item No. 46109-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ext
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Trifurcated Transpac IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoir and Needleless Valve, Item No. 46108-36 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pr
Terminated		 DRSNone listed
Nov 15, 2016ICU Medical, Inc.
Bifurcated Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blue Stripe PT Tubing, Item No. 46107-68 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pre
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Monitoring Kit w/03 ml Squeeze Flush and Macrodrip, Item No. 46106-91 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces be
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Monitoring Kit w/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way Stopcocks, Blue Plugs and Needleless Valve, Item No. 46106-49 The Transpac Disposable Straight Pressure Transducer (DSPT)
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Monitoring Kit w/Safeset 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves 1 Bonded, Item No. 46104-75 The Transpac Disposable Straight Pressure Transducer (DS
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo Flush, Pall Air Filter, Macrodrip (Pole Mount), Item No. 46104-63 The Transpac Disposable Straight Pressure Transducer (DSPT) is
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK, Item No. 46104-35 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transd
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Red Stripe Pressure Tubing and Color Plug, Item No. 46104-31 The Transpac Disposable Straight Pressure Transducer
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP AND RED PLUGS, Item No. 46104-10 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces be
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Monitoring Kit w/Safeset 72" Pressure Tubing, Reservoir, 03 ml Squeeze Flush and 2 Needleless Valves, Item No. 46103-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac IV Monitoring Kit w/ Safeset Reservoir, 24" Tubing,03 ml Intraflo Flush and Needleless Valve, Item No. 46103-68 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRANSPAC IV TRIFURCATED MONITORING KIT 72", 3 DISPOSABLE TRANSDUCERS, 3 3 ML INTRAFLO FLUSHES, MACRODRIP (POLE MOUNT), Item No. 46101-39 The Transpac Disposable Straight Pressure Transducer (DSPT) is
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac w/Safeset Reservoir, Squeeze 03 ml Flush and Needleless Valve, Item No. 46101-82 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that inter
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Trifurcated Monitoring Kit w/84" Safeset" Reservoir, TP4, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-55 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pr
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-53 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transd
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac IV and 48" HP Tubing, Item No. 46100-87 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascu
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Cath Lab Kit w/Waste Bag System, 3 Port "OFF" Manifold (600 psi), Transpac IV, 72" Spike Sets and 48" HP Tubing, Item No. 46100-83 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ext
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
5 Port "OFF" Manifold w/TRANSPAC IV, Item No. 46100-29 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressu
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Transpac 4 kit w/72" Macrodrip Admin Set, Item No. 46099-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and p
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressu
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Quad Kit W/03ML Flush Device, Mounts, Reservoir & TP4, Item No. 46099-24 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a c
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Cath Lab Kit w/03 ml Squeeze Flush, Pressure Tubing, Guidewire, 10 cc Syringes and 3 Way Stopcock, Item No. 46098-87NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular p
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK, Item No. 46098-79 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transdu
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
4 PORT "OFF" MANIFOLD, w/HP STOPCOCK, WASTE BAG ASSY, 10 cc SYRINGE & AD SETS, Item No. 46098-78 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer tha
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CATH LAB KIT w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, Item No. 46098-76 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transd
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduc
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No. 46098-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that in
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Cath Lab Kit w/Waste Bag, dyePod, Sosa Spike & Syringe, Item No. 46098-11 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-66 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduc
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-65 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduc
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cathet
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwee
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interface
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED. CTR, Item No. 46097-33 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwee
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG. M.C., Item No. 46097-30 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a c
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. 46096-26 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer t
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by convertin
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP., Item No. 46095-33 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwee
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP, Item No. 46095-22 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cath
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Cath Lab Kit w/3 Port "ON" Manifold, 03 ml Flush Device, Waste Bag, HPT, Syringe, TP4 and 30 ml Contrast Reservoir, Item No. 46095-16 The Transpac Disposable Straight Pressure Transducer (DSPT) is an
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Neonate Kit With 30 ml Flush Device For Driscoll Foundation For Children, Item No. 46094-71 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that int
Terminated		 DRSK061573

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