The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Multitrack Angiographic Catheter.
Device ID | K003902 |
510k Number | K003902 |
Device Name: | MULTITRACK ANGIOGRAPHIC CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
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 | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-12-19 |
Decision Date | 2001-01-11 |