The following data is part of a premarket notification filed by Medi-tech, Inc. with the FDA for Medi-tech Platform Guide Catheter.
| Device ID | K952345 |
| 510k Number | K952345 |
| Device Name: | MEDI-TECH PLATFORM GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MEDI-TECH, INC. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Darlene A Thometz |
| Correspondent | Darlene A Thometz MEDI-TECH, INC. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-19 |
| Decision Date | 1995-08-17 |