The following data is part of a premarket notification filed by Chestnut Medical Technologies, Inc. with the FDA for Alligator-hd Retrieval Device (ard-hd), Model Fa-88840-xx.
| Device ID | K093977 |
| 510k Number | K093977 |
| Device Name: | ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX |
| Classification | Catheter, Percutaneous |
| Applicant | CHESTNUT MEDICAL TECHNOLOGIES, INC. 173 JEFFERSON DRIVE Menlo Park, CA 94025 -1114 |
| Contact | Daniel Cher |
| Correspondent | Daniel Cher CHESTNUT MEDICAL TECHNOLOGIES, INC. 173 JEFFERSON DRIVE Menlo Park, CA 94025 -1114 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2010-04-22 |
| Summary: | summary |