The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Tyshak Mini Pediatric Ptv Catheter, Model 107.
| Device ID | K003276 |
| 510k Number | K003276 |
| Device Name: | TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| 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 | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-19 |
| Decision Date | 2000-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046964339981 | K003276 | 000 |
| 04046964339653 | K003276 | 000 |
| 04046964339677 | K003276 | 000 |
| 04046964339691 | K003276 | 000 |
| 04046964339714 | K003276 | 000 |
| 04046964339738 | K003276 | 000 |
| 04046964339752 | K003276 | 000 |
| 04046964339776 | K003276 | 000 |
| 04046964339790 | K003276 | 000 |
| 04046964339813 | K003276 | 000 |
| 04046964339837 | K003276 | 000 |
| 04046964339851 | K003276 | 000 |
| 04046964339912 | K003276 | 000 |
| 04046964339936 | K003276 | 000 |
| 04046964339950 | K003276 | 000 |
| 04046964339639 | K003276 | 000 |