The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Pta, Ptv, Atrioseptostomy, Angiographic, Sizing Catheters.
Device ID | K011557 |
510k Number | K011557 |
Device Name: | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS |
Classification | Catheter, Septostomy |
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 | DXF |
Subsequent Product Code | DQO |
Subsequent Product Code | LIT |
CFR Regulation Number | 870.5175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-21 |
Decision Date | 2001-07-12 |