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 | K210012 |
| 510k Number | K210012 |
| Device Name: | Tamarin Blue PTCA RX Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | Natec Medical Ltd. Maeva Centra Building, Silicon Avenue Ebene Business Park Reduit, MU 72201 |
| Contact | Roy Devassy Pallippatt |
| Correspondent | Candace Cederman CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, MD 21401 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-04 |
| Decision Date | 2021-07-09 |