The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Supercross Microcatheter (130 Cm), Supercross Microcatheter (150 Cm) Model 5300, 5301.
| Device ID | K101659 |
| 510k Number | K101659 |
| Device Name: | SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 |
| Classification | Catheter, Percutaneous |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Matt Nienstedt |
| Correspondent | Matt Nienstedt VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-11 |
| Decision Date | 2010-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M20653410 | K101659 | 000 |
| 30841156100470 | K101659 | 000 |
| 30841156100463 | K101659 | 000 |
| 30841156100456 | K101659 | 000 |
| 30841156100449 | K101659 | 000 |
| 30841156100432 | K101659 | 000 |
| 30841156100425 | K101659 | 000 |
| 30841156100418 | K101659 | 000 |
| 30841156100401 | K101659 | 000 |
| 30841156100395 | K101659 | 000 |
| 30841156100388 | K101659 | 000 |
| 30841156100494 | K101659 | 000 |
| M20653000 | K101659 | 000 |
| M20653400 | K101659 | 000 |
| M20653090 | K101659 | 000 |
| M20653080 | K101659 | 000 |
| M20653070 | K101659 | 000 |
| M20653060 | K101659 | 000 |
| M20653050 | K101659 | 000 |
| M20653040 | K101659 | 000 |
| M20653030 | K101659 | 000 |
| M20653020 | K101659 | 000 |
| M20653010 | K101659 | 000 |
| 30841156100371 | K101659 | 000 |