The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Cardiovascular Spring Guide Wire.
Device ID | K834223 |
510k Number | K834223 |
Device Name: | CARDIOVASCULAR SPRING GUIDE WIRE |
Classification | Wire, Guide, Catheter |
Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-06 |
Decision Date | 1984-02-13 |