The following data is part of a premarket notification filed by Intensive Technology, Inc. with the FDA for Intra-operative Tec Atherectomy System.
| Device ID | K922970 |
| 510k Number | K922970 |
| Device Name: | INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| 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 | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-19 |
| Decision Date | 1993-01-13 |