The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Tyshak And Z-med Ptv Catheters.
| Device ID | K003114 |
| 510k Number | K003114 |
| Device Name: | NUMED TYSHAK AND Z-MED PTV CATHETERS |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | NUMED, INC. P.O BOX 129 Nicholville, NY 12965 |
| Contact | Nichelle R Laflesh |
| Correspondent | Nichelle R Laflesh NUMED, INC. P.O BOX 129 Nicholville, NY 12965 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-05 |
| Decision Date | 2000-11-01 |