The following data is part of a premarket notification filed by Creganna-tactx Medical with the FDA for Empira Rx Ptca Dilatation Catheter, Empria Nc Rx Ptca Dilatation Catheter.
| Device ID | K110133 |
| 510k Number | K110133 |
| Device Name: | EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | CREGANNA-TACTX MEDICAL 1353 DELL AVENUE Campbell, CA 95008 |
| Contact | Dennis Wong |
| Correspondent | Dennis Wong CREGANNA-TACTX MEDICAL 1353 DELL AVENUE Campbell, CA 95008 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-18 |
| Decision Date | 2011-06-10 |
| Summary: | summary |