510(k) K034025

NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC by Nmt Medical, Inc. — Product Code DYB

K034025 is an FDA 510(k) premarket notification submitted by Nmt Medical, Inc. for the device "NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC". The FDA issued a decision of Substantially Equivalent on March 26, 2004. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Nmt Medical, Inc. has at least 1 other 510(k) clearance on record.