FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101
K Number: K020693
·
Decision Sep 5, 2002
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
393
Applicant Total
4
Review Days
185
Basic Information
- Device Name
- AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101
- K Number
- K020693
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EMBOL-X, INC.
- Date Received
- March 4, 2002
- Decision Date
- September 5, 2002
- Product Code
- DWF
- 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by EMBOL-X, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K022071 | EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 | Feb 14, 2003 | Substantially Equivalent |
| K002973 | EMBOL-X INTRODUCER, MODEL CF00200 | Apr 26, 2001 | Substantially Equivalent |
| K980631 | EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA | Feb 2, 1999 | Substantially Equivalent |