The following data is part of a premarket notification filed by Intensive Technology, Inc. with the FDA for 0.014 Peripheral Guide Wire.
| Device ID | K882804 |
| 510k Number | K882804 |
| Device Name: | 0.014 PERIPHERAL GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. San Diego, CA 92123 |
| Contact | Michael Klicpera |
| Correspondent | Michael Klicpera INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. San Diego, CA 92123 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-07 |
| Decision Date | 1988-10-28 |