The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Modified Numed Balloon Angiographic Catheter.
Device ID | K883948 |
510k Number | K883948 |
Device Name: | MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER |
Classification | Catheter, Flow Directed |
Applicant | NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
Contact | Allen J Tower |
Correspondent | Allen J Tower NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
Product Code | DYG |
CFR Regulation Number | 870.1240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-13 |
Decision Date | 1989-04-21 |