The following data is part of a premarket notification filed by C.r.bard, Inc. with the FDA for Accucath Intravascular Catheter.
Device ID | K162894 |
510k Number | K162894 |
Device Name: | AccuCath Intravascular Catheter |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | C.R.BARD, INC. 605 N 5600 W Salt Lake City, UT 84116 |
Contact | Jacob Lee |
Correspondent | Jacob Lee C.R.BARD, INC. 605 N 5600 W Salt Lake City, UT 84116 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-17 |
Decision Date | 2016-11-15 |
Summary: | summary |