The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Innerchange Micro-introducer Catheter, Models 7900 Through 7905.
| Device ID | K062627 |
| 510k Number | K062627 |
| Device Name: | INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Patrice Stromberg |
| Correspondent | Patrice Stromberg VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-05 |
| Decision Date | 2007-01-05 |
| Summary: | summary |