The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Angiogtaphic Catheter.
| Device ID | K915414 |
| 510k Number | K915414 |
| Device Name: | TERUMO ANGIOGTAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Winston Umemuran |
| Correspondent | Winston Umemuran TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-02 |
| Decision Date | 1992-02-04 |