510(k) K020587
- Device
- PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046
- Applicant
- PULSION MEDICAL SYSTEMS AG
- 510(k) number
- K020587
- Product code
- KRB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-05-23
- Date received
- 2002-02-22
- Regulation
- 870.1915
- Classification name
- Probe, Thermodilution
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES M DELANEY
- Address
- 100 Main St. Suite 120 Concord MA US 01742 01742
FDA Registration Numbers#
- 1721676
- 9617594
- 9615817
- 3032916632
- 3009077524
- 1018233
- 1625425
- 3016701404
- 3013500228
- 3000126629
- 3012528160
- 9610816
- 3009001657
- 3015309643
- 1644312
- 3002807090
- 3038188187
- 2025816
- 1651104
- 3032109181
- 3008729547
- 3010421104
- 8043983
- 3013679558
- 9610105
- 3013596024
- 3012536737
- 8020616
- 3004111573
- 3001570235
- 2032112
- 3006082230
- 3012359877
- 9710602
- 3005941719
- 3003263092
- 3033589330
- 1720929
- 3013319212
- 3008483389
- 3004977335
- 8010042
- 3005877899
- 3008496528
- 2648727
- 3004832480
- 1713468
- 2648045
- 3006950086
Source Documents#
Other 510(k) Records For Product Code KRB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171620 | PiCCO Catheter | Pulsion Medical Systems SE | 2018-02-21 |
| K100739 | VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 | Edwards Lifesciences, LLC | 2010-12-07 |
| K072364 | PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES | Pulsion Medical Systems AG | 2007-09-19 |
| K991886 | PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR | Pulsion Medical Systems, Inc. | 2000-05-11 |
| K936182 | CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT | Ohmeda Medical | 1994-03-25 |
| K915627 | PACEVIEW | Micromedical Industries, Ltd. | 1992-03-27 |
| K912172 | SAFEWEDGE(TM) RELIEF VALVE DEVICE | Sunscope Intl., Inc. | 1991-09-27 |
| K902627 | INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. | Biometric Research Institute, Inc. | 1991-02-25 |
| K900710 | INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER | Intec Medical, Inc. | 1990-10-19 |
| K900317 | PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER | Elecath | 1990-06-22 |
| K892941 | CCO SYSTEM MODEL SP1467,SP5567,SP6267 | Spectramed, Inc. | 1989-11-06 |
| K884318 | THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM | Abbott Laboratories | 1988-12-13 |
| K881893 | NUMED BALLOON THERMODILUTION CATHETER | NuMED, Inc. | 1988-09-06 |
| K874522 | MODIFIED MYOCARDIAL TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1988-01-29 |
| K864818 | ACKRAD TDI SET | Ackrad Laboratories | 1987-04-09 |
Legacy Summary#
summary
FDA Review#
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