510(k) K932188 ยท KRA Catheter, Continuous Flush
SAFESET RESERVOIR
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Oct 25, 1993 |
| Received | May 6, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932188
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66
Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascula Terminated |
DRS | None listed |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient Mount), Item No. 42648-06
Product Usage:
The Tr Terminated |
DRS | None listed |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66
Product Usage:
The Transpac Disposable Straight Pressure Transducer ( Terminated |
DRS | None listed |
| Sep 15, 2016 | ICU Medical, Inc. Monitoring Kit with 30mL Flush Device, Item No. 46076-15
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a Terminated |
DRS | None listed |
| Sep 15, 2016 | ICU Medical, Inc. Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces b Terminated |
DRS | None listed |
| Sep 15, 2016 | ICU Medical, Inc. Monitoring Kit with 03mL Flush Device, Item No. 46080-57
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a Terminated |
DRS | None listed |
| Sep 15, 2016 | ICU Medical, Inc. Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces b Terminated |
DRS | None listed |
| Sep 15, 2016 | ICU Medical, Inc. Pediatric Kit with 30mL Flush Device, Item No. 46099-10
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a Terminated |
DRS | None listed |
| Sep 15, 2016 | ICU Medical, Inc. 5 Port OFF Manifold with Transpac IV, Item No. 46100-29
Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter Terminated |
DRS | None listed |
| Sep 15, 2016 | ICU Medical, Inc. Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22
Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that Terminated |
DRS | None listed |
| Sep 15, 2016 | ICU Medical, Inc. TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65
Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressur Terminated |
DRS | None listed |
| Sep 15, 2016 | ICU Medical, Inc. Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) i Terminated |
DRS | None listed |
| Mar 15, 2005 | Hospira Inc. Angiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir. Terminated |
DQO | None listed |
| Mar 15, 2005 | Hospira Inc. Angiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir. Terminated |
DQO | None listed |
| Mar 15, 2005 | Hospira Inc. Angiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir. Terminated |
DQO | None listed |
| Mar 15, 2005 | Hospira Inc. Angiographic Syringe, 12 cc Palm Pad with Rotator Reservoir. Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.