The following data is part of a premarket notification filed by Radius Medical, Llc with the FDA for Progigy Support Catheter.
| Device ID | K130714 |
| 510k Number | K130714 |
| Device Name: | PROGIGY SUPPORT CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | RADIUS MEDICAL, LLC 577 Main St Ste 360 Hudson, MA 01749 |
| Contact | Richard Demello |
| Correspondent | Richard Demello RADIUS MEDICAL, LLC 577 Main St Ste 360 Hudson, MA 01749 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-15 |
| Decision Date | 2013-08-22 |
| Summary: | summary |