The following data is part of a premarket notification filed by Sunscope Intl., Inc. with the FDA for Heparin Coated Thermodilution Cath & Accessories.
| Device ID | K911710 |
| 510k Number | K911710 |
| Device Name: | HEPARIN COATED THERMODILUTION CATH & ACCESSORIES |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SUNSCOPE INTL., INC. 1775 SHAWNESS COURT Westlake Village, CA 91362 |
| Contact | Keith Chan |
| Correspondent | Keith Chan SUNSCOPE INTL., INC. 1775 SHAWNESS COURT Westlake Village, CA 91362 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-17 |
| Decision Date | 1991-10-23 |