The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Deflecting Guide Wire.
Device ID | K833242 |
510k Number | K833242 |
Device Name: | DEFLECTING GUIDE WIRE |
Classification | Accessories, Catheter, G-u |
Applicant | VAN-TEC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNY |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-18 |
Decision Date | 1983-10-19 |