The following data is part of a premarket notification filed by Intensive Technology, Inc. with the FDA for Tec Rotating Dual Hemovalve.
| Device ID | K912664 |
| 510k Number | K912664 |
| Device Name: | TEC ROTATING DUAL HEMOVALVE |
| Classification | Introducer, Catheter |
| Applicant | INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. San Diego, CA 92123 |
| Contact | Michael E Klicpera |
| Correspondent | Michael E Klicpera INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. San Diego, CA 92123 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-18 |
| Decision Date | 1992-08-24 |