The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Starclose Hex-hub Dilator.
| Device ID | K062554 |
| 510k Number | K062554 |
| Device Name: | STARCLOSE HEX-HUB DILATOR |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | ABBOTT VASCULAR INC. 400 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Daun Putnam |
| Correspondent | Daun Putnam ABBOTT VASCULAR INC. 400 SAGINAW DR. Redwood City, CA 94063 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-30 |
| Decision Date | 2007-02-06 |
| Summary: | summary |