The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Grebset Micro-introducer Kit, Models 7950, 7951.
| Device ID | K081846 |
| 510k Number | K081846 |
| Device Name: | GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Charmaine Sutton |
| Correspondent | Charmaine Sutton 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 | 2008-06-30 |
| Decision Date | 2009-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M20679520 | K081846 | 000 |
| M20679511 | K081846 | 000 |
| M20679501 | K081846 | 000 |
| M20679410 | K081846 | 000 |