The following data is part of a premarket notification filed by Intensive Technology, Inc. with the FDA for Peripheral Atherectomy System.
| Device ID | K890515 |
| 510k Number | K890515 |
| Device Name: | PERIPHERAL ATHERECTOMY SYSTEM |
| Classification | Stripper, Artery, Intraluminal |
| Applicant | INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. San Diego, CA 92123 |
| Contact | R Crawford |
| Correspondent | R Crawford INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. San Diego, CA 92123 |
| Product Code | DWX |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-01 |
| Decision Date | 1989-05-23 |