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 |