FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
K Number: K940795
·
Decision May 24, 1994
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
98
Applicant Total
11
Review Days
91
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Basic Information
- Device Name
- SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
- K Number
- K940795
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Edwards
- Date Received
- February 22, 1994
- Decision Date
- May 24, 1994
- Product Code
- DYG
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYG | Catheter, Flow Directed | FDA class 2 | Cardiovascular |
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Other Clearances by Baxter Edwards
| K Number | Device Name | ||
|---|---|---|---|
| K993816 | BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD | May 4, 2000 | Substantially Equivalent |
| K981909 | BAXTER HEMOSTASIS VALVE INTRODUCERS | Nov 24, 1998 | Substantially Equivalent |
| K980487 | CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM | Jul 7, 1998 | Substantially Equivalent |
| K965137 | FOGARTY VALVULOTOME MODEL 700091 | Jun 4, 1997 | Substantially Equivalent |
| K964021 | INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) | Mar 27, 1997 | Substantially Equivalent |
| K955839 | MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER | Mar 25, 1996 | Substantially Equivalent |
| K952638 | 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ | Jul 28, 1995 | Substantially Equivalent |
| K944214 | BAXTER HANDLE MODEL 1150 | Feb 10, 1995 | Substantially Equivalent |
| K944858 | BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS | Jan 5, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K926433 | 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 | Mar 23, 1993 | Substantially Equivalent |