The following data is part of a premarket notification filed by Medi-dyne, Inc. with the FDA for 4f-7f Medi-dyne Torq Flow Xlb Angiographic Catheter.
| Device ID | K000825 |
| 510k Number | K000825 |
| Device Name: | 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | MEDI-DYNE, INC. 604 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Norman Hall |
| Correspondent | Norman Hall MEDI-DYNE, INC. 604 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-14 |
| Decision Date | 2000-09-21 |