The following data is part of a premarket notification filed by Galt Medical with the FDA for Triv(tm) Valved Tearaway Introducer, Tirv(tm) Valved Tearaway Introducer With Side Port.
| Device ID | K112398 |
| 510k Number | K112398 |
| Device Name: | TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT |
| Classification | Introducer, Catheter |
| Applicant | GALT MEDICAL 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518 |
| Contact | Betsy Cortelloni |
| Correspondent | Betsy Cortelloni GALT MEDICAL 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-19 |
| Decision Date | 2012-04-12 |
| Summary: | summary |