FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter
K Number: K181023
·
Decision May 17, 2018
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
85
Applicant Total
4
Review Days
30
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
- Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter
- K Number
- K181023
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meril Life Sciences Private Limited
- Date Received
- April 17, 2018
- Decision Date
- May 17, 2018
- Product Code
- LOX
- 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 |
|---|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOX), ordered by most recent decision date.
Firefighter Pro PTCA Balloon Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
FLASH Flex Aorto-Ostial Angioplasty System
FDA 510(k)
FDA Class 2
·Cardiovascular
Ryurei
FDA 510(k)
FDA Class 2
·Cardiovascular
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Pantera Pro; Pantera LEO
FDA 510(k)
FDA Class 2
·Cardiovascular
Sapphire NC ULTRA Coronary Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular