The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Tyshak Mini Pediatric Ptv Catheter.
Device ID | K032591 |
510k Number | K032591 |
Device Name: | NUMED TYSHAK MINI PEDIATRIC PTV CATHETER |
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 | 2003-08-22 |
Decision Date | 2003-09-25 |
Summary: | summary |