The following data is part of a premarket notification filed by Pryor Medical Devices, Inc with the FDA for Er-reboa Catheter.
| Device ID | K151821 |
| 510k Number | K151821 |
| Device Name: | ER-REBOA Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Pryor Medical Devices, Inc 229 North Masin Street Boeme, TX 78006 |
| Contact | Christopher Banas |
| Correspondent | Semih Oktay CardioMed Device Consultants, LLC 18905 Celebrity Lane Sandy Spring, MD 20860 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-06 |
| Decision Date | 2015-10-23 |
| Summary: | summary |