The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Microferret Catheter.
Device ID | K961668 |
510k Number | K961668 |
Device Name: | MICROFERRET CATHETER |
Classification | Catheter, Continuous Flush |
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 | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-30 |
Decision Date | 1996-11-04 |
Summary: | summary |