The following data is part of a premarket notification filed by Invatec Innovative Technologies with the FDA for Sailor Plus Percutaneous Transluminal Angioplasty (pta) Catheter, Model Saexxxxxxxxx.
| Device ID | K042538 |
| 510k Number | K042538 |
| Device Name: | SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX |
| Classification | Catheter, Percutaneous |
| Applicant | INVATEC INNOVATIVE TECHNOLOGIES 4600 Nathan Lane North Plymouth, MN 55442 |
| Contact | Mike Winegar |
| Correspondent | Mike Winegar INVATEC INNOVATIVE TECHNOLOGIES 4600 Nathan Lane North Plymouth, MN 55442 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-20 |
| Decision Date | 2004-11-08 |
| Summary: | summary |