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 |