The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Ghost Ii Pta Catheters.
Device ID | K003972 |
510k Number | K003972 |
Device Name: | NUMED GHOST II PTA CATHETERS |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
Contact | Nichell Laflesh |
Correspondent | Nichell Laflesh NUMED, INC. 2880 MAIN ST. Hopkinton, 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 | 2000-12-22 |
Decision Date | 2001-01-11 |