SINGLE USE SELDINGER/COURNAND PERC. NDL
Device Facts
| Record ID | K810859 |
|---|---|
| Device Name | SINGLE USE SELDINGER/COURNAND PERC. NDL |
| Applicant | Procedure Products, Inc. |
| Product Code | DRE · Cardiovascular |
| Decision Date | Apr 11, 1981 |
| 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.
