FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19
K Number: K090665
·
Decision May 22, 2009
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
35
Applicant Total
6
Review Days
70
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19
- K Number
- K090665
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Vascular-Vascular Solutions
- Date Received
- March 13, 2009
- Decision Date
- May 22, 2009
- Product Code
- NTE
- 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 |
|---|---|---|---|
| NTE | Temporary Carotid Catheter For Embolic Capture | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NTE), ordered by most recent decision date.
EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
FDA 510(k)
FDA Class 2
·Cardiovascular
ENROUTE® Transcarotid Neuroprotection System
FDA 510(k)
FDA Class 2
·Cardiovascular
ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
WIRION Embolic Protection System
FDA 510(k)
FDA Class 2
·Cardiovascular
WIRION
FDA 510(k)
FDA Class 2
·Cardiovascular
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Abbott Vascular-Vascular Solutions
| K Number | Device Name | ||
|---|---|---|---|
| K090509 | FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER | Mar 20, 2009 | Substantially Equivalent |
| K081523 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Sep 11, 2008 | Substantially Equivalent |
| K072708 | ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM | Aug 18, 2008 | Unknown |
| K080264 | MODIFICATION TO: FOX PLUS PTA CATHETER | Mar 26, 2008 | Substantially Equivalent |
| K072798 | VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER | Jan 31, 2008 | Substantially Equivalent |