FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRUS ASCENT OCCLUSION BALLOON CATHETER
K Number: K080861
·
Decision Aug 27, 2008
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
89
Applicant Total
23
Review Days
153
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
- MICRUS ASCENT OCCLUSION BALLOON CATHETER
- K Number
- K080861
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micrus Endovascular Corporation
- Date Received
- March 27, 2008
- Decision Date
- August 27, 2008
- Product Code
- MJN
- 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 |
|---|---|---|---|
| MJN | Catheter, Intravascular Occluding, Temporary | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MJN), ordered by most recent decision date.
pREBOA-PRO Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Bridge Plus Occlusion Balloon (590-002)
FDA 510(k)
FDA Class 2
·Cardiovascular
preCARDIA Occlusion System
FDA 510(k)
FDA Class 2
·Cardiovascular
LANDMARK REBOA Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Fogarty Occlusion Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
RenovoCath
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Micrus Endovascular Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K103780 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO | Jan 26, 2011 | Substantially Equivalent |
| K102818 | MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE | Dec 3, 2010 | Substantially Equivalent |
| K092702 | MICRUS MICROCATHETER, MODEL COURIER 270 | Nov 20, 2009 | Substantially Equivalent |
| K091504 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 | Jun 19, 2009 | Substantially Equivalent |
| K083922 | MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 | May 6, 2009 | Substantially Equivalent |
| K090274 | MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE | Mar 3, 2009 | Substantially Equivalent |
| K083646 | MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL | Jan 2, 2009 | Substantially Equivalent |
| K082739 | MICRUS MICROCOIL DELIVERY SYSTEM | Oct 17, 2008 | Substantially Equivalent |
| K080379 | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT | Jun 30, 2008 | Substantially Equivalent |
| K080437 | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF | May 8, 2008 | Substantially Equivalent |