The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Revasc Thrombectomy Device.
| Device ID | K132281 |
| 510k Number | K132281 |
| Device Name: | REVASC THROMBECTOMY DEVICE |
| Classification | Catheter, Embolectomy |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Amarilys Machado |
| Correspondent | Amarilys Machado Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-23 |
| Decision Date | 2013-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704074779 | K132281 | 000 |