The following data is part of a premarket notification filed by Portex Ltd. with the FDA for Wallace (sure View) Embryo Replacement Catheter And Trial Transfer Catheter.
| Device ID | K033084 |
| 510k Number | K033084 |
| Device Name: | WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER |
| Classification | Catheter, Assisted Reproduction |
| Applicant | PORTEX LTD. MILITARY ROAD Hythe, Kent, GB Ct21 6db |
| Contact | Steve Ogilvie |
| Correspondent | Steve Ogilvie PORTEX LTD. MILITARY ROAD Hythe, Kent, GB Ct21 6db |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2003-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888937021241 | K033084 | 000 |
| 30888937021234 | K033084 | 000 |
| 30888937021180 | K033084 | 000 |
| 30888937021173 | K033084 | 000 |