The following data is part of a premarket notification filed by Intratherapeutics, Inc. with the FDA for Iti Intramax Guide Catheter 91, 78 And 65.
| Device ID | K981191 |
| 510k Number | K981191 |
| Device Name: | ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 |
| Classification | Catheter, Percutaneous |
| Applicant | INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-02 |
| Decision Date | 1999-04-07 |
| Summary: | summary |