The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Microcruiser Plus Introducer Set.
| Device ID | K011790 |
| 510k Number | K011790 |
| Device Name: | MICROCRUISER PLUS INTRODUCER SET |
| Classification | Introducer, Catheter |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville, FL 32608 |
| Contact | Karl Swartz |
| Correspondent | Karl Swartz MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville, FL 32608 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-08 |
| Decision Date | 2001-09-05 |
| Summary: | summary |