CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001
FDA 510(k) clearance K031920 · decided 2003-07-23
Clearance details
- K-number
- K031920
- Device name
- CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001
- Applicant
- Trans Vascular Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2003-06-23
- Decision date
- 2003-07-23
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactur recall (Z-0208-2007) | Medtronic Vascular | 2006-11-22 |