The following data is part of a premarket notification filed by Chestnut Medical Technologies, Inc. with the FDA for Alligator Retrieval Device (ard).
| Device ID | K043580 |
| 510k Number | K043580 |
| Device Name: | ALLIGATOR RETRIEVAL DEVICE (ARD) |
| Classification | Catheter, Percutaneous |
| Applicant | CHESTNUT MEDICAL TECHNOLOGIES, INC. 3583 ROSS ROAD Palo Alto, CA 94303 |
| Contact | Anna Longwell |
| Correspondent | Patricia Murphy KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-12-28 |
| Decision Date | 2005-03-24 |
| Summary: | summary |