The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Modified Ptca Guiding Catheters.
Device ID | K862975 |
510k Number | K862975 |
Device Name: | MODIFIED PTCA GUIDING CATHETERS |
Classification | Catheter, Percutaneous |
Applicant | CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
Contact | Donna L Rogers |
Correspondent | Donna L Rogers CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-29 |
Decision Date | 1986-09-23 |