The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Cordis Ptca Guiding Catheter, Modification.
Device ID | K913783 |
510k Number | K913783 |
Device Name: | CORDIS PTCA GUIDING CATHETER, MODIFICATION |
Classification | Catheter, Percutaneous |
Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Contact | Erin Mcgurk-burleson |
Correspondent | Erin Mcgurk-burleson DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-14 |
Decision Date | 1991-10-18 |