Biosense Webster, Inc. · Class II · Cleared May 10, 2000
| K-number | 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 |
| Device class | Class II |
| Decision date | May 10, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov