The following data is part of a premarket notification filed by Daig Corp. with the FDA for Spyglass 5 Fr Angiographic Catheter.
| Device ID | K982299 |
| 510k Number | K982299 |
| Device Name: | SPYGLASS 5 FR ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | Michael G Schultz |
| Correspondent | Michael G Schultz DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-01 |
| Decision Date | 1998-10-19 |
| Summary: | summary |