The following data is part of a premarket notification filed by Intensive Technology, Inc. with the FDA for Ivt Guiding Catheter.
| Device ID | K911869 |
| 510k Number | K911869 |
| Device Name: | IVT GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. San Diego, CA 92123 |
| Contact | Keven E Daly |
| Correspondent | Keven E Daly INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. San Diego, CA 92123 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-26 |
| Decision Date | 1991-10-16 |