FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STINGRAY ORIENTING BALLOON CATHETER
K Number: K101591
·
Decision Aug 6, 2010
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
14
Review Days
60
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
- STINGRAY ORIENTING BALLOON CATHETER
- K Number
- K101591
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bridgepoint Medical
- Date Received
- June 7, 2010
- Decision Date
- August 6, 2010
- Product Code
- DQY
- 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 |
|---|---|---|---|
| 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 Bridgepoint Medical
| K Number | Device Name | ||
|---|---|---|---|
| K122795 | STINGRAY GUIDEWIRES | Nov 8, 2012 | Substantially Equivalent |
| K121745 | MANTARAY GUIDEWIRES | Jul 13, 2012 | Substantially Equivalent |
| K120533 | BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES | May 22, 2012 | Substantially Equivalent |
| K120881 | MANTARAY GUIDEWIRES | Apr 18, 2012 | Substantially Equivalent |
| K120129 | MANTARAY CATHETER | Feb 3, 2012 | Substantially Equivalent |
| K113589 | BIGBOSS CATHETER | Jan 4, 2012 | Substantially Equivalent |
| K111963 | BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER | Aug 10, 2011 | Substantially Equivalent |
| K111488 | MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 | Jun 30, 2011 | Substantially Equivalent |
| K091841 | BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 | Sep 2, 2009 | Substantially Equivalent |
| K081130 | BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER | May 14, 2009 | Substantially Equivalent |