FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
K Number: K122070
·
Decision Aug 15, 2012
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
12
Review Days
30
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Basic Information
- Device Name
- CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
- K Number
- K122070
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trireme Medical, Inc.
- Date Received
- July 16, 2012
- Decision Date
- August 15, 2012
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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Other Clearances by Trireme Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133633 | CHOCOLATE PTCA BOLLOON CATHETER | Jun 2, 2014 | Substantially Equivalent |
| K130414 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 | Jun 15, 2013 | Substantially Equivalent |
| K121681 | GLIDER PTCA BALLOON CATHETER | Jun 26, 2012 | Substantially Equivalent |
| K121402 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G | Jun 8, 2012 | Substantially Equivalent |
| K120677 | CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) | Mar 15, 2012 | Substantially Equivalent |
| K111544 | GLIDER PTCA BALLOON CATHETER | Mar 2, 2012 | Substantially Equivalent |
| K111738 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) | Dec 14, 2011 | Substantially Equivalent |
| K112281 | GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX | Aug 17, 2011 | Substantially Equivalent |
| K103534 | GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE | Jan 5, 2011 | Substantially Equivalent |
| K101062 | GLIDER PTA BALLOON CATHETER | May 12, 2010 | Substantially Equivalent |