PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
Device Facts
| Record ID | K001139 |
|---|---|
| Device Name | PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M |
| Applicant | Biosense Webster, Inc. |
| Product Code | DYB · Cardiovascular |
| Decision Date | May 10, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.
