The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Balt Introducer.
| Device ID | K925633 |
| 510k Number | K925633 |
| Device Name: | BALT INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538 |
| Contact | Grace Carland |
| Correspondent | Grace Carland TARGET THERAPEUTICS 47201 LAKEVIEW BLVD. P.O. BOX 5120 Freemont, CA 94538 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-09 |
| Decision Date | 1993-06-25 |