The following data is part of a premarket notification filed by Reflow Medical with the FDA for Wingman Extendable Tip Support Catheter.
| Device ID | K101479 |
| 510k Number | K101479 |
| Device Name: | WINGMAN EXTENDABLE TIP SUPPORT CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | REFLOW MEDICAL 5311 FOXHOUND WAY San Diego, CA 92130 |
| Contact | Rebecca Pine |
| Correspondent | Rebecca Pine REFLOW MEDICAL 5311 FOXHOUND WAY San Diego, CA 92130 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-28 |
| Decision Date | 2010-08-11 |
| Summary: | summary |