The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Concentroc Hd Guide Catheter, Models 90017 (4f), 90019 (5f), 90021 (6f), 90022 (7f), 90023 (8f), 90024 (9f).
| Device ID | K003880 |
| 510k Number | K003880 |
| Device Name: | CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) |
| Classification | Catheter, Percutaneous |
| Applicant | CONCENTRIC MEDICAL, INC. 2585 LEGHORN ST. Moutian View, CA 94043 |
| Contact | Sam Lazzara |
| Correspondent | Sam Lazzara CONCENTRIC MEDICAL, INC. 2585 LEGHORN ST. Moutian View, CA 94043 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-15 |
| Decision Date | 2001-05-16 |