510(k) K993245
- Device
- CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM
- Applicant
- ALBA CRITICAL CARE LTD
- 510(k) number
- K993245
- Product code
- DYG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-10-28
- Date received
- 1999-09-28
- Regulation
- 870.1240
- Classification name
- Catheter, Flow Directed
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TED VANDER WIEDE
- Address
- Phoenix Crescent, Strathclyde Business Park Bellshill, Lanarkshire GB ML4 3NJ ML4 3NJ
FDA Registration Numbers#
- 1721676
- 9615817
- 3032916632
- 2521402
- 1018233
- 9680794
- 2523676
- 3004091615
- 1625425
- 1061927
- 2011171
- 1220948
- 3002807314
- 1061124
- 2025816
- 3017060084
- 1000563940
- 1317547
- 1035166
- 1319639
- 2024311
- 3013162291
- 2649622
- 3038791046
- 3004784537
- 3014656749
- 3015859709
- 3004111573
- 2939561
- 3013300026
- 3006082230
- 2024168
- 1720929
- 3013319212
- 3013764800
- 3006425876
- 3010532612
- 9680260
- 3004832480
- 1713468
- 3003289723
- 2182208
- 2648045
- 2133641
- 3005718570
- 9673241
Source Documents#
Other 510(k) Records For Product Code DYG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | Edwards Lifesciences | 2024-12-09 |
| K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) | Edwards Lifesciences | 2024-06-27 |
| K233824 | Swan-Ganz catheter | Edwards Lifesciences, LLC | 2024-06-06 |
| K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform | Edwards Lifesciencess, LLC | 2023-09-21 |
| K222117 | Swang-Ganz IQ pulmonary artery catheter | Edwards Lifesiences, LLC | 2022-12-09 |
| K193466 | Swan-Ganz Catheters | Edwards Lifesciences, LLC | 2020-02-16 |
| K160084 | Swan Ganz Catheters | Edwards Lifesciences, LLC | 2016-05-03 |
| K094048 | PERCUPRO MESSENGER BALLOON CATHETER | Cardiosolutions, Inc. | 2011-07-14 |
| K081052 | OCCLUSION BALLOON CATHETER, MODEL VENOS | Oscor, Inc. | 2008-06-18 |
| K010253 | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 | Transonic Systems, Inc. | 2002-03-19 |
| K012225 | ATTAIN 6215 VENOGRAM BALLOON CATHETER | Medtronic Vascular | 2001-08-28 |
| K003118 | Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 | Zcv ,Inc. | 2000-12-20 |
| K001063 | SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 | Baxter Healthcare Corp | 2000-07-07 |
| K963336 | HARMAC THERMODILUTION CATHETER | Harmac Medical Products, Inc. | 1997-08-14 |
| K955816 | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR | Baxter Healthcare Corp | 1997-05-06 |
Legacy Summary#
summary
FDA Review#
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