The following data is part of a premarket notification filed by Nmt Medical, Inc. with the FDA for Nmt Medical Transseptal Sheath Set, Models Tss-10-hsc, Tss-11-hsc, Tss12-hsc.
| Device ID | K034025 |
| 510k Number | K034025 |
| Device Name: | NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC |
| Classification | Introducer, Catheter |
| Applicant | NMT MEDICAL, INC. 27-43 WORMWOOD ST. Boston, MA 02210 |
| Contact | Anne M Kulis |
| Correspondent | Anne M Kulis NMT MEDICAL, INC. 27-43 WORMWOOD ST. Boston, MA 02210 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-29 |
| Decision Date | 2004-03-26 |
| Summary: | summary |