INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
Device Facts
| Record ID | K002847 |
|---|---|
| Device Name | INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX |
| Applicant | Maxxim Medical |
| Product Code | DYB · Cardiovascular |
| Decision Date | May 31, 2001 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
