The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Modification To Numed Tyshak Ii And Z-med Ii Ptv Catheters.
| Device ID | K030589 |
| 510k Number | K030589 |
| Device Name: | MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS |
| Classification | Catheter, Percutaneous |
| Applicant | NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Contact | Nichelle R Laflesh |
| Correspondent | Nichelle R Laflesh NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-25 |
| Decision Date | 2003-05-21 |
| Summary: | summary |