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 |