Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
FDA 510(k) clearance K003118 · decided 2000-12-20
Clearance details
- K-number
- K003118
- Device name
- Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
- Applicant
- Zcv ,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-05
- Decision date
- 2000-12-20
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- DYG
- Device class
- 2
- Regulation number
- 870.1240
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (K242451) | Edwards Lifesciences | 2024-12-09 |
| 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) (K233983) | Edwards Lifesciences | 2024-06-27 |
| Swan-Ganz catheter (K233824) | Edwards Lifesciences, LLC | 2024-06-06 |
| Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform (K231248) | Edwards Lifesciencess, LLC | 2023-09-21 |
| Swang-Ganz IQ pulmonary artery catheter (K222117) | Edwards Lifesiences, LLC | 2022-12-09 |
| Swan-Ganz Catheters (K193466) | Edwards Lifesciences, LLC | 2020-02-16 |
| Swan Ganz Catheters (K160084) | Edwards Lifesciences, LLC | 2016-05-03 |
| PERCUPRO MESSENGER BALLOON CATHETER (K094048) | Cardiosolutions, Inc. | 2011-07-14 |
| OCCLUSION BALLOON CATHETER, MODEL VENOS (K081052) | Oscor, Inc. | 2008-06-18 |
| ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 (K010253) | Transonic Systems, Inc. | 2002-03-19 |
| ATTAIN 6215 VENOGRAM BALLOON CATHETER (K012225) | Medtronic Vascular | 2001-08-28 |
| SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 (K001063) | Baxter Healthcare Corp | 2000-07-07 |
Recalls involving this device
No recalls on record reference this clearance.