FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS
K Number: K101570
·
Decision Jul 13, 2010
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
89
Applicant Total
3
Review Days
39
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
- HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS
- K Number
- K101570
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Therapeutics Dba Ev3 Neurovascular
- Date Received
- June 4, 2010
- Decision Date
- July 13, 2010
- 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