EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
FDA 510(k) clearance K110133 · decided 2011-06-10
Clearance details
- K-number
- K110133
- Device name
- EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
- Applicant
- Creganna-Tactx Medical
- Decision
- Substantially Equivalent
- Date received
- 2011-01-18
- Decision date
- 2011-06-10
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- LOX
- Device class
- 2
- Regulation number
- 870.5100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Campbell, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Creganna-Tactx Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cordis EMPIRA NC RX PTCA Dilatation Catheter recall (Z-2556-2014) | Cordis Corporation | 2014-08-28 |
| Cordis EMPIRA RX PTCA Dilatation Catheter recall (Z-2557-2014) | Cordis Corporation | 2014-08-28 |
| Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use. recall (Z-1784-2014) | Cordis Corporation | 2014-06-11 |