The following data is part of a premarket notification filed by Natec Medical Ltd with the FDA for Tamarin Blue Ptca Rx Dilatation Catheter.
| Device ID | K112735 |
| 510k Number | K112735 |
| Device Name: | TAMARIN BLUE PTCA RX DILATATION CATHETER |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | NATEC MEDICAL LTD 1468 Harwell Avenue Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith NATEC MEDICAL LTD 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-20 |
| Decision Date | 2012-11-02 |
| Summary: | summary |