Cleared Traditional

NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC

K034025 · Nmt Medical, Inc. · Cardiovascular

Mar 2004

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K034025 is an FDA 510(k) clearance for the NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Nmt Medical, Inc. (Boston, US). The FDA issued a Cleared decision on March 26, 2004, 88 days after receiving the submission on December 29, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K034025 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2003
Decision Date	March 26, 2004
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF