The following data is part of a premarket notification filed by Intensive Technology, Inc. with the FDA for Modified Ivt Peripheral Atherectomy System.
| Device ID | K896403 |
| 510k Number | K896403 |
| Device Name: | MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. San Diego, CA 92123 |
| Contact | Kevin E Daly |
| Correspondent | Kevin E Daly INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. San Diego, CA 92123 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-07 |
| Decision Date | 1990-03-06 |