The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Dover Silver Temperature Sensing Foley Catheter.
| Device ID | K042709 |
| 510k Number | K042709 |
| Device Name: | DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Wei Zhao |
| Correspondent | Wei Zhao TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-09-30 |
| Decision Date | 2005-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521149236 | K042709 | 000 |
| 10884521149229 | K042709 | 000 |