AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
Device Facts
| Record ID | K842113 |
|---|---|
| Device Name | AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT |
| Applicant | Mallinckrodt Critical Care |
| Product Code | DRE · Cardiovascular |
| Decision Date | Jul 13, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1310 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.
