The following data is part of a premarket notification filed by Microvention, Inc., A Terumo Group Company with the FDA for Pg Pro Microcatheter.
| Device ID | K192625 |
| 510k Number | K192625 |
| Device Name: | PG Pro Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | MicroVention, Inc., A Terumo Group Company 35 Enterprise Aliso Viejo, CA 92656 |
| Contact | Ganesh Balachandar |
| Correspondent | Ganesh Balachandar MicroVention, Inc., A Terumo Group Company 35 Enterprise Aliso Viejo, CA 92656 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-23 |
| Decision Date | 2019-11-21 |