The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Epidural Catheter.
| Device ID | K062005 |
| 510k Number | K062005 |
| Device Name: | PORTEX EPIDURAL CATHETER |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Cynthia Engelhardt |
| Correspondent | Cynthia Engelhardt SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-17 |
| Decision Date | 2006-10-18 |
| Summary: | summary |