FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLIDER PTA BALLOON CATHETER
K Number: K094019
·
Decision Feb 12, 2010
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
12
Review Days
45
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
- GLIDER PTA BALLOON CATHETER
- K Number
- K094019
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trireme Medical, Inc.
- Date Received
- December 29, 2009
- Decision Date
- February 12, 2010
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQY), ordered by most recent decision date.
Amplatzer TorqVue Exchange System
FDA 510(k)
FDA Class 2
·Cardiovascular
Perfect-O Ostial Positioning Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer TorqVue Delivery System
FDA 510(k)
FDA Class 2
·Cardiovascular
Teleport Glide Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
FDA 510(k)
FDA Class 2
·Cardiovascular
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K122070 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G | Aug 15, 2012 | 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 |