The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Portex 24g Pediatric Epidural And Peripheral Block Anesthesia Catheter.
| Device ID | K033080 |
| 510k Number | K033080 |
| Device Name: | PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER |
| Classification | Anesthesia Conduction Kit |
| Applicant | PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Cindy Engelhardt |
| Correspondent | Cindy Engelhardt PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2004-03-10 |
| Summary: | summary |