The following data is part of a premarket notification filed by Intec Medical, Inc. with the FDA for Giant Lumen Safetip Series: Endomyocardial Biopsy.
| Device ID | K903840 |
| 510k Number | K903840 |
| Device Name: | GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY |
| Classification | Introducer, Catheter |
| Applicant | INTEC MEDICAL, INC. P.O. BOX 2186 35A CHERRY HILL DRIVE Danvers, MA 01923 |
| Contact | Kenneth Spector |
| Correspondent | Kenneth Spector INTEC MEDICAL, INC. P.O. BOX 2186 35A CHERRY HILL DRIVE Danvers, MA 01923 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-21 |
| Decision Date | 1990-10-16 |