The following data is part of a premarket notification filed by Vascular Pathways, Inc. with the FDA for Accucath Bc Intravascular Catheter System.
| Device ID | K140504 |
| 510k Number | K140504 |
| Device Name: | ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | VASCULAR PATHWAYS, INC. 1847 Trade Center Way Naples, FL 34109 |
| Contact | Bill Bold |
| Correspondent | Bill Bold VASCULAR PATHWAYS, INC. 1847 Trade Center Way Naples, FL 34109 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2014-07-17 |
| Summary: | summary |