The following data is part of a premarket notification filed by Fuji Systems Corporation with the FDA for Cello Ii Balloon Guide Catheter.
| Device ID | K223275 |
| 510k Number | K223275 |
| Device Name: | CELLO II Balloon Guide Catheter |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Fuji Systems Corporation 200-2, Aza-Ohira, Odakura, Nishigo Nishi Shirakawa Gun, JP 961-8061 |
| Contact | Yoshiyuki Suzuki |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-10-24 |
| Decision Date | 2022-12-09 |