The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Accent Dg(tm) Balloon Angioplasty Catheter.
| Device ID | K900677 |
| 510k Number | K900677 |
| Device Name: | ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Contact | April Lavender |
| Correspondent | April Lavender COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-12 |
| Decision Date | 1991-02-22 |