FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CROSS-PILOT TURBO ELITE SUPPORT CATHETER
K Number: K090913
·
Decision May 4, 2009
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
24
Review Days
33
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
- CROSS-PILOT TURBO ELITE SUPPORT CATHETER
- K Number
- K090913
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectranetics Corp.
- Date Received
- April 1, 2009
- Decision Date
- May 4, 2009
- 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 Spectranetics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K140047 | LEXICONTURE MECHANICAL DILATOR SHEATH SET | Apr 9, 2014 | Substantially Equivalent |
| K123632 | 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 | Jan 25, 2013 | Substantially Equivalent |
| K112032 | 8FR TURBO - TANDEM SYSTEM | Oct 17, 2011 | Substantially Equivalent |
| K093257 | TORQMAX SHEATH GRIP ACCESSORY | Mar 26, 2010 | Substantially Equivalent |
| K094036 | TURBO-TANDEM SYSTEM MODEL 472-110 | Jan 25, 2010 | Substantially Equivalent |
| K092378 | SPECTRANETICS VISISHEATH DILATOR SHEATH | Nov 2, 2009 | Substantially Equivalent |
| K092396 | SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS | Sep 4, 2009 | Substantially Equivalent |
| K091299 | SPECTRANETICS TURBO-TANDEM SYSTEM | Jul 1, 2009 | Substantially Equivalent |
| K082559 | SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER | Dec 11, 2008 | Substantially Equivalent |
| K082561 | SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS | Dec 10, 2008 | Substantially Equivalent |