The following data is part of a premarket notification filed by Msi, Inc. with the FDA for Introstat Lead Introducer.
| Device ID | K960200 |
| 510k Number | K960200 |
| Device Name: | INTROSTAT LEAD INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | MSI, INC. 615 JASMINE AVENUE N. Tarpon Springs, FL 34689 |
| Contact | Larry G Junker |
| Correspondent | Larry G Junker MSI, INC. 615 JASMINE AVENUE N. Tarpon Springs, FL 34689 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-03 |
| Decision Date | 1996-07-02 |